Product Details

UREA 40% CRM 28.35 GM

Manufacturer: Major

MFG#: 00904-7167-23

NDC: 00904-7167-23

PID: 248985

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Product Properties:

Description -
Description N
Description -
DESI Drug Ind -
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind NR
DESI2 Drug Ind NR
Drug Category -
Drug Category -
Drug Category USES: Urea is used to treat dry/rough skin conditions (such as eczema, psoriasis, corns, callus) and some nail problems (such as ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.
Drug Type Code N
Drug Type Code COMMON BRAND NAME(S): Kerafoam, Keralac, Kerol, Umecta
Drug Type Code N
FDA Approval Date 10/14/2021
FDA Approval Date 10/14/2021
FDA Therap Equiv GM
FDA Therap Equiv GM
HCPCS -
HCPCS 1
HCPCS -
Market Entry Date -
Market Entry Date -
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date (ue-REE-a)
Termination Date 1
Termination Date 1
Unit 28
Unit 28
Units Per Pkg 07/06/2021
Units Per Pkg 07/06/2021
Active Ingredients 2015 urea 57136
Active Ingredients 2015 urea 57136
Active Ingredients 2015 urea 57136
AHFS Class 84280000 KERATOLYTIC AGENTS
AHFS Class 84280000 KERATOLYTIC AGENTS
AHFS Class 84280000 KERATOLYTIC AGENTS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form CREAM (GRAM)
Dose Form CREAM (GRAM)
Dose Form CREAM (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 16308 urea TOPICAL CREAM (G) 40 %
Gen Code and Des 16308 urea TOPICAL CREAM (G) 40 %
Gen Code and Des 16308 urea TOPICAL CREAM (G) 40 %
Inactive Ingredients 2468 propylene glycol 57556
Inactive Ingredients 2468 propylene glycol 57556
Inactive Ingredients 2468 propylene glycol 57556
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 40%
Strength 40%
Strength 40%
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Kerafoam, Keralac, Kerol, Umecta
Common Brand Name COMMON BRAND NAME(S): Kerafoam, Keralac, Kerol, Umecta
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction -
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 28
Drug Form Pack Size 28
Drug Form Pack Size 28
Form CREAM
Form CREAM
Form CREAM
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 28.35
Unit Size 28.35
Unit Size 28.35
How to Use -
How to Use HOW TO USE: Use this product as directed. Follow all directions on the product package and prescription label. If you have any questions, ask your doctor or pharmacist. Some products need to be shaken well before use. Check the label to see whether you should shake the bottle. Apply to the affected areas of the skin/nails, usually 1 to 3 times a day or as directed by your doctor. Rub in well until absorbed. Wash your hands after applying unless you are treating the hands. How often you apply the medication will depend on the product and your skin condition. Apply to the skin/nails only. Avoid sensitive areas such as your eyes, lips, inside your mouth/nose, and the vaginal/groin area, unless your doctor directs you otherwise. Ask your doctor or check the label for directions about any areas or types of skin where you should not apply the product (such as the face, broken/chapped/cut/irritated/scraped skin, or recently shaved skin). Ask your doctor if you should cover the treated area with a bandage or gauze. Consult your doctor or pharmacist for more details. Use this medication regularly to get the most benefit from it. Tell your doctor if your condition lasts or gets worse.
How to Use HOW TO USE: Use this product as directed. Follow all directions on the product package and prescription label. If you have any questions, ask your doctor or pharmacist. Some products need to be shaken well before use. Check the label to see whether you should shake the bottle. Apply to the affected areas of the skin/nails, usually 1 to 3 times a day or as directed by your doctor. Rub in well until absorbed. Wash your hands after applying unless you are treating the hands. How often you apply the medication will depend on the product and your skin condition. Apply to the skin/nails only. Avoid sensitive areas such as your eyes, lips, inside your mouth/nose, and the vaginal/groin area, unless your doctor directs you otherwise. Ask your doctor or check the label for directions about any areas or types of skin where you should not apply the product (such as the face, broken/chapped/cut/irritated/scraped skin, or recently shaved skin). Ask your doctor if you should cover the treated area with a bandage or gauze. Consult your doctor or pharmacist for more details. Use this medication regularly to get the most benefit from it. Tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not use more of this product or use it more often to catch up.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not use more of this product or use it more often to catch up.
Missed Dose 28
Notes GM
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose NR
Phonetic Pronunciation -
Phonetic Pronunciation (ue-REE-a)
Phonetic Pronunciation (ue-REE-a)
Precautions PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin cuts/infections/sores. Some products may make you more sensitive to the sun. Check the label for any warnings or ask your doctor or pharmacist whether you need to take any special precautions when in the sun. Your doctor/pharmacist may suggest that you limit your time in the sun, avoid tanning booths and sunlamps, and use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Some products may stain/discolor clothing. Ask your doctor or pharmacist for more details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if drug passes into breast milk. Consult your doctor before breast-feeding, especially if you are applying this product to the breast area.
Precautions -
Precautions PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin cuts/infections/sores. Some products may make you more sensitive to the sun. Check the label for any warnings or ask your doctor or pharmacist whether you need to take any special precautions when in the sun. Your doctor/pharmacist may suggest that you limit your time in the sun, avoid tanning booths and sunlamps, and use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Some products may stain/discolor clothing. Ask your doctor or pharmacist for more details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if drug passes into breast milk. Consult your doctor before breast-feeding, especially if you are applying this product to the breast area.
Side Effects -
Side Effects SIDE EFFECTS: Burning, itching, stinging, redness, or irritation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: unusual changes in the skin (such as blistering, peeling), signs of skin infection. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Burning, itching, stinging, redness, or irritation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: unusual changes in the skin (such as blistering, peeling), signs of skin infection. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature. Do not freeze. Store foam product away from heat and open flame. Because the contents of the foam canister are under pressure, do not puncture or burn the container. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage 07/06/2021
Storage STORAGE: Store at room temperature. Do not freeze. Store foam product away from heat and open flame. Because the contents of the foam canister are under pressure, do not puncture or burn the container. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses -
Uses USES: Urea is used to treat dry/rough skin conditions (such as eczema, psoriasis, corns, callus) and some nail problems (such as ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.
Uses USES: Urea is used to treat dry/rough skin conditions (such as eczema, psoriasis, corns, callus) and some nail problems (such as ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.

Frequently Asked Questions (FAQs)

The cost of UREA 40% CRM 28.35 GM is $available for registerd members only

UREA 40% CRM 28.35 GM is manufactured by Major.

You can purchase UREA 40% CRM 28.35 GM on our website at https://supplies.pipelinemedical.com/product/detail/urea-40-crm-28-35-gm-248985