Label: HYDROCORTISONE cream
- NDC Code(s): 84387-005-01
- Packager: ALLIED TRADE LINK LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2024
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DOSAGE & ADMINISTRATION
Purpose
Hydrocortisone USP 1% ............................................................................................................................................................................................................................................ Antipruritic (Anti-Itch)
Uses
For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak,
poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching -
WARNINGS
For External Use Only
If pregnant or breast-feeding, ask a health professional before use
Do not use In the eyes 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 rectum by using fingers or any mechanical device or applicator
Ask a doctor before use if you are using any other hydrocortisone product
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 (do not
continue to use this or any other hydrocortisone product for longer than 7 days) Bleeding occurs due to anal itching - INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84387-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) STEARIC ACID (UNII: 4ELV7Z65AP) WHITE PETROLATUM (UNII: B6E5W8RQJ4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84387-005-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 11/12/2024 Labeler - ALLIED TRADE LINK LLC (029033682) Registrant - ALLIED TRADE LINK LLC (029033682) Establishment Name Address ID/FEI Business Operations GOLPALDAS VISRAM AND COMPANY LIMITED 858030888 manufacture(84387-005)