Label: MEIJER ANTI ITCH- hydrocortisone ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 41250-338-28 - Packager: Meijer, Inc.
- Category: HUMAN OTC DRUG LABEL
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 July 23, 2019
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- ACTIVE INGREDIENT
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PURPOSE
Uses
- temporary relieves 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, and psoriasis
- 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
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Direections
- 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: consult 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 soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEIJER ANTI ITCH
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-338 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PETROLATUM (UNII: 4T6H12BN9U) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-338-28 1 in 1 CARTON 01/15/2015 1 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 not final part348 01/15/2015 Labeler - Meijer, Inc. (006959555)