Label: HYDROCORTISONE cream
- NDC Code(s): 71399-0180-1, 71399-0180-2
- Packager: AKRON PHARMA INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 26, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
-
Uses
temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- insect bites
- poison ivy or sumac
- soaps
- detergents
- cosmetics
- jewelry,
- seborrheic dermatitis
- poison oak
- psoriasis
- temporarily relieves external anal and genital itching
- Other uses of this product should be undertaken only under the advice and supervision of a doctor.
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of Reach of Children
-
Directions
for itching of skin irritation, inflammation, and rashes:
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
for external anal and genital itching, adults:
- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
- Other Information
- Inactive Ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-0180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 mg in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71399-0180-1 454 g in 1 JAR; Type 0: Not a Combination Product 11/05/2021 2 NDC:71399-0180-2 1 in 1 CARTON 11/20/2023 2 28 g in 1 TUBE; 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 11/05/2021 Labeler - AKRON PHARMA INC (067878881)