Label: HYDROCORTISONE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50382-010-01, 50382-010-02 - Packager: Galentic Pharma (India) Priva Te Limited
- 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 August 7, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose:
- Warnings:
- Do not use:
- Stop use and ask a physician if:
- Keep out of reach of children
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Directions:
Adults and children over 2 years of age
- Apply evenly to affected area no more than 3 or 4 times daily.
- Do not use
- consult a physician
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
- apply externally to the area up to 6 times daily or after each bowel movement
- Other information:
- Inactive ingredients:
- INDICATIONS & USAGE
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-010 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) EDETATE DISODIUM (UNII: 7FLD91C86K) MINERAL OIL (UNII: T5L8T28FGP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-010-01 28.3 g in 1 TUBE 2 NDC:50382-010-02 425 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/07/2013 Labeler - Galentic Pharma (India) Priva Te Limited (918531450)