Product Details

ZINC OXIDE 20% ONT 454 GM

Manufacturer: Major

MFG#: 00536-1316-98

NDC: 00536-1316-98

PID: 277508

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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind NR
DESI2 Drug Ind -
Drug Category N
Drug Category -
Drug Type Code N
Drug Type Code 2
FDA Approval Date 08/16/2021
FDA Approval Date 03/01/2021
FDA Therap Equiv NR
FDA Therap Equiv GM
HCPCS -
HCPCS -
Market Entry Date 08/16/2021
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date 2
Unit 454
Unit GM
Units Per Pkg 454
Units Per Pkg 03/01/2021
Active Ingredients 1922 zinc oxide 1314132
Active Ingredients 1922 zinc oxide 1314132
AHFS Class 84241200 BASIC OINTMENTS AND PROTECTANTS
AHFS Class 84241200 BASIC OINTMENTS AND PROTECTANTS
DEA Class NC
DEA Class NC
Dose Form OINTMENT (GRAM)
Dose Form OINTMENT (GRAM)
Fine Line Class 010001200129 Gnrc External Pain Relief
Fine Line Class 010001200129 Gnrc External Pain Relief
Gen Code and Des 5576 zinc oxide TOPICAL OINT. (G) 20 %
Gen Code and Des 5576 zinc oxide TOPICAL OINT. (G) 20 %
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
Product Category OT Over the Counter
Product Category OT Over the Counter
Strength 20%
Strength 20%
Common Brand Name COMMON BRAND NAME(S): Caldesene, Desitin, Elta Seal
Common Brand Name COMMON BRAND NAME(S): Caldesene, Desitin, Elta Seal
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.
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 454
Drug Form Pack Size 454
Form OINTMENT
Form OINTMENT
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
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
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 454
Unit Size 454
How to Use HOW TO USE: Use this medication on the skin only. Follow all directions on the product package or use as directed by your doctor. If you have any questions, ask your doctor or pharmacist. Avoid getting this medication in the eyes. If you do get the medication in the eyes, flush with plenty of water. If you are using the spray, shake the container well before each use. This medication should start working within 12 hours. Tell your doctor if your condition gets worse, does not improve, lasts for more than 7 days, or occurs again after a few days.
How to Use HOW TO USE: Use this medication on the skin only. Follow all directions on the product package or use as directed by your doctor. If you have any questions, ask your doctor or pharmacist. Avoid getting this medication in the eyes. If you do get the medication in the eyes, flush with plenty of water. If you are using the spray, shake the container well before each use. This medication should start working within 12 hours. Tell your doctor if your condition gets worse, does not improve, lasts for more than 7 days, or occurs again after a few days.
Missed Dose MISSED DOSE: Not applicable.
Missed Dose MISSED DOSE: Not applicable.
Notes NOTES: Keep all medical and lab appointments. To help prevent diaper rash, check your baby's diaper often, and change the diaper whenever it appears wet/dirty.
Notes NOTES: Keep all medical and lab appointments. To help prevent diaper rash, check your baby's diaper often, and change the diaper whenever it appears wet/dirty.
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.
Phonetic Pronunciation (zink OX-ide)
Phonetic Pronunciation (zink OX-ide)
Precautions PRECAUTIONS: Before using zinc oxide, 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. If you have the following health problem, consult your doctor or pharmacist before using this product: skin infection in the affected area. Tell your doctor if you are pregnant before using this medication. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using zinc oxide, 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. If you have the following health problem, consult your doctor or pharmacist before using this product: skin infection in the affected area. Tell your doctor if you are pregnant before using this medication. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: If your doctor has directed you to use this medication, remember that 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: skin irritation. 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: If your doctor has directed you to use this medication, remember that 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: skin irritation. 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: Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. 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 STORAGE: Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. 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: This medication is used to treat and prevent diaper rash and other minor skin irritations (such as burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.
Uses USES: This medication is used to treat and prevent diaper rash and other minor skin irritations (such as burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Frequently Asked Questions (FAQs)

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ZINC OXIDE 20% ONT 454 GM is manufactured by Major.

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