Label: HYDROCORTISONE cream
- NDC Code(s): 47682-211-12, 47682-211-35, 47682-211-73, 47682-211-99
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
- for the temporary relief of itching associated with minor skin irritations, inflamation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
- other uses of this product should be only under the advice and supervision of a doctor
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WARNINGS
Warnings
For external use only
Do not use
- for the treatment of diaper rash
- with anyother Hydrocortisone product unless you have consulted adoctor
- if you have vaginal discharge, consulkt a doctor
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DOSAGE & ADMINISTRATION
Directions
- for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily
- children under 12 years of age: for external anal itching, consult a doctor
- children under 2 years of age: do not use, consult a doctor
- adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or botting with toilet tissue or a soft cloth before application of this product
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
- Medi-First Hydrocortisone Label
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-211 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 ALCOHOL (UNII: 3K9958V90M) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-211-73 25 in 1 BOX 04/15/2013 1 NDC:47682-211-99 0.9 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:47682-211-12 10 in 1 BOX 04/15/2013 2 NDC:47682-211-99 0.9 g in 1 POUCH; Type 0: Not a Combination Product 3 NDC:47682-211-35 144 in 1 BOX 04/15/2013 3 NDC:47682-211-99 0.9 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 04/15/2013 Labeler - Unifirst First Aid Corporation (832947092)