Product Details

FLUOCINOLONE 0.01% BODY OIL 118.28 ML

Manufacturer: TARO PHARMACEUTICAL INDUSTRIES LTD

MFG#: 51672-1356-08

NDC: 51672-1356-08

PID: 304770

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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind NR
Drug Category NJ
Drug Type Code N
FDA Approval Date 05/20/2016
FDA Therap Equiv ML
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 118
Units Per Pkg 05/19/2016
Active Ingredients 2193 fluocinolone acetonide 67732
AHFS Class 84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE)
DEA Class NC
Dose Form OIL (ML)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 7507 fluocinolone acetonide TOPICAL OIL 0.01 %
Inactive Ingredients 568 peanut
OMP Family -
Product Category RX Pharmaceuticals
Strength 0.01%
Common Brand Name COMMON BRAND NAME(S): Derma-Smoothe/FS
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 -
Case Quantity 12
Drug Form Pack Size 118
Form OIL
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AT Topical products therapeutically equivalent in same dosage form.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 118.28
How to Use HOW TO USE: Shake well before each use. Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor. Do not apply this medication to the diaper area. Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in as directed by your doctor, usually 3 times daily. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. After applying the medication, wash your hands unless you are using this medication to treat the hands. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water. Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed. Tell your doctor if your condition lasts or gets worse after 2 weeks.
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 double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details.
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 (FLOO-oh-SIN-oh-lone)
Precautions PRECAUTIONS: Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil), 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. Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Notify your doctor promptly if redness, swelling, or irritation does not improve. Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Stinging, burning, irritation, dryness, or redness at the application site may occur. Acne, excessive hair growth, small red bumps on the skin (folliculitis), skin thinning/discoloration, or stretch marks may also 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. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. 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. 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 eczema, a skin condition which causes red, irritated, and itchy skin. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.

Frequently Asked Questions (FAQs)

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FLUOCINOLONE 0.01% BODY OIL 118.28 ML is manufactured by TARO PHARMACEUTICAL INDUSTRIES LTD.

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