Label: HYDROCORTISONE ACETATE cream
- 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.
Updated May 6, 2016
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- ACTIVE INGREDIENT
Indications and Usage
- in the eyes
- longer than 1 week unless directed by a physician
- for diaper rash
- if you have vaginal discharge
- more than the recommended daily dosage unless directed by a doctor
- in the rectum bu using fingers or any other mechanical device or applicator
- For temporary relief of minor skin irritations and external itching.
- Stop use and ask a physician if:
- Keep out of reach of children
Dosage and Administration
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
- Principal Display Panel
INGREDIENTS AND APPEARANCE
hydrocortisone acetate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63777-224 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 CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63777-224-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 09/06/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/29/2011 Labeler - Kinray Inc. (012574513) Registrant - Dynarerx Corporation (008124539) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Pvt. Ltd. 864201135 manufacture(63777-224) Establishment Name Address ID/FEI Business Operations Blossom Pharmaceuticals 677381470 manufacture(63777-224)