Label: GELMICIN HYDROCORTISONE WITH ALOE- hydrocortisone cream
- NDC Code(s): 65923-035-40
- Packager: United Exchange Corp.
- 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 May 10, 2022
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- ACTIVE INGREDIENT
-
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 advise and supervision of a doctor
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions
- before first use, remove or puncture seal under cap by using the tip of the cap
- for itching of skin irritation, inflammation, and rashes:
- adults and children 2 years 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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GELMICIN HYDROCORTISONE WITH ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-035 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 SODIUM LAURYL SULFATE (UNII: 368GB5141J) ALUMINIUM SULFATE OCTADECAHYDRATE (UNII: TCS9L00G8F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WHITE WAX (UNII: 7G1J5DA97F) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) ALOE VERA LEAF (UNII: ZY81Z83H0X) CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H) PROPYLPARABEN (UNII: Z8IX2SC1OH) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-035-40 1 in 1 CARTON 02/22/2021 1 40 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 02/22/2021 Labeler - United Exchange Corp. (840130579)