Label: LUCKY SUPERSOFT MAXIMUM STRENGTH- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 47046-176-01 - Packager: Anicare Pharmaceuticals Pvt. Ltd.
- 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 December 20, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Uses
■ temporarily relieves itching associated with minor skin irritations and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should be 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
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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 doctorfor external anal and genital itching, adults: ■ when practical, clean the affected area with mild soap and 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
- Package Label
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INGREDIENTS AND APPEARANCE
LUCKY SUPERSOFT MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47046-176 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM SULFATE (UNII: 34S289N54E) YELLOW WAX (UNII: 2ZA36H0S2V) CALCIUM ACETATE (UNII: Y882YXF34X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ICODEXTRIN (UNII: 2NX48Z0A9G) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47046-176-01 14 g in 1 TUBE; Type 0: Not a Combination Product 01/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/31/2015 Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)