Label: HYDROCORTISONE- hydrocortisone acetate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67777-224-01, 67777-224-02 - Packager: Dynarex Corporation
- 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 April 5, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Warnings:
- Purpose
- Do not use:
- Stop use and ask a physician if:
- Keep out of reach of children
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Directions:
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
- When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.
- Other information:
- Inactive ingredients:
- INDICATIONS & USAGE
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-224 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) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) SODIUM METABISULFITE (UNII: 4VON5FNS3C) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-224-01 28.3 g in 1 TUBE; Type 0: Not a Combination Product 02/02/2010 2 NDC:67777-224-02 0.9 g in 1 PACKET; Type 0: Not a Combination Product 02/02/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/02/2010 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539)