Label: HYDROCORTISONE cream
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NDC Code(s):
47682-397-12,
47682-397-35,
47682-397-71,
47682-397-73, view more47682-397-99
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 17, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
- OTHER SAFETY INFORMATION
- QUESTIONS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-397 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:47682-397-71 20 in 1 BOX 04/15/2013 07/01/2019 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-397-12 10 in 1 BOX 04/15/2013 07/01/2019 2 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-397-73 25 in 1 BOX 06/06/2016 3 NDC:47682-397-99 0.9 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:47682-397-35 144 in 1 BAG 06/30/2017 4 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 Drug M017 04/15/2013 Labeler - Unifirst First Aid Corporation (832947092)