Label: MEIJER MAX. STRENGTH ANTI-ITCH CREAM INTENSIVE HEALING FORMULA- hydrocortisone cream
- NDC Code(s): 41250-259-57
- Packager: MEIJER, INC.
- 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.
Drug Label Information
Updated March 31, 2022
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- ACTIVE INGREDIENT
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PURPOSE
Uses
temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- jewelry
- insect bites
- soaps
- cosmetics
- detergents
- seborrheic dermatitis
- poison ivy, oak sumac
temporarily relieves external anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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, clean 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
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients aloe vera leaf, .alpha.-tocopherol acetate, benzyl alcohol, cetyl alcohol, dimethicone 350, edetate disodium, gelatin hydrolysate, glycerin, glyceryl stearate/peg-100 stearate, magnesium ascorbyl phosphate, matricaria chamomilla flowering top, menthyl lactate, methyl gluceth-20, methylparaben, pretrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, steareth-2, steareth-21, stearyl alcohol, vitamin a palmitate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEIJER MAX. STRENGTH ANTI-ITCH CREAM INTENSIVE HEALING FORMULA
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-259 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) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 60 (UNII: CAL22UVI4M) STEARETH-21 (UNII: 53J3F32P58) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) DIMETHICONE 350 (UNII: 2Y53S6ATLU) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) METHYL GLUCETH-20 (UNII: J3QD0LD11P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) BENZYL ALCOHOL (UNII: LKG8494WBH) PETROLATUM (UNII: 4T6H12BN9U) STEARETH-2 (UNII: V56DFE46J5) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-259-57 1 in 1 CARTON 07/16/2020 1 57 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 not final part348 07/16/2020 Labeler - MEIJER, INC. (006959555)