Label: AFTATE HYDROCORTISONE CREAM- hydrocortisone cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70356-201-01 - Packager: Sabel Med LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 31, 2016
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
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- PURPOSE
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AFTATE HYDROCORTISONE CREAM
hydrocortisone cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70356-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MINERAL OIL (UNII: T5L8T28FGP) CETETH-20 (UNII: I835H2IHHX) EDETATE DISODIUM (UNII: 7FLD91C86K) CHLOROCRESOL (UNII: 36W53O7109) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70356-201-01 28 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/01/2016 Labeler - Sabel Med LLC (091476000)
