Label: FUCIDIN- sodium fusidate ointment
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated October 7, 2019
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
For external use only.
Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.
Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.
When using this product consult a doctor before exceeding recommended dosage.
Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
sodium fusidate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72988-0015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSIDATE SODIUM (UNII: J7P3696BCQ) (FUSIDIC ACID - UNII:59XE10C19C) FUSIDIC ACID 20 mg in 1 g Inactive Ingredients Ingredient Name Strength DIPROPYLENE GLYCOL (UNII: E107L85C40) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72988-0015-1 10 g in 1 TUBE; Type 0: Not a Combination Product 10/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/08/2019 Labeler - Lydia Co., Ltd. (695735569) Registrant - Lydia Co., Ltd. (695735569) Establishment Name Address ID/FEI Business Operations I World Pharmaceutical Co., Ltd. 688222857 manufacture(72988-0015) Establishment Name Address ID/FEI Business Operations Lydia Co., Ltd. 695735569 label(72988-0015)