Label: HYDROCORTISONE (antipruritic- anti-itch cream
- NDC Code(s): 67777-003-01
- 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.
Updated September 18, 2020
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- Active Ingredient
For external use only
Do not use
- in the yes
- for diaper rash
- for external genital or feminine itching if you have a vaginal discharge
- more than the recommended daily dosage unless directed by a doctor
- this product in the rectumby using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product.
- in case of bleeding when used for anal itching
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 time 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
- 1137 Label
INGREDIENTS AND APPEARANCE
antipruritic (anti-itch) cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-003 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 POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) MINERAL OIL (UNII: T5L8T28FGP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM METABISULFITE (UNII: 4VON5FNS3C) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-003-01 1728 in 1 CASE 05/03/2018 1 144 in 1 BOX 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/03/2018 Labeler - Dynarex Corporation (008124539)