Label: HYDROCORTISONE- cool relief gel with aloe gel
- NDC Code(s): 0363-0363-01
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 25, 2024
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- Drug Facts
- Drug Facts
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Drug Facts
Uses:
■ temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak and sumac ■insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should oonly be under the advise and supervison of a doctor
- Warnings: For external use only
- 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
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 ■ If pregnant or breast-feeding: ask a health professional before use. ■ 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
- Inactive ingredients:
- SAFE HANDLING WARNING
- Cool Relief Gel 1oz Tube
- Cool Relief Gel 1oz
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
cool relief gel with aloe gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0363 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 ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) DIMETHICONE (UNII: 92RU3N3Y1O) METHYL LACTATE, L- (UNII: 0379G9C44S) METHYL GLUCETH-20 (UNII: J3QD0LD11P) PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO) ALCOHOL (UNII: 3K9958V90M) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) MALTODEXTRIN (UNII: 7CVR7L4A2D) OAT (UNII: Z6J799EAJK) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) ICODEXTRIN (UNII: 2NX48Z0A9G) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOHEXADECANE (UNII: 918X1OUF1E) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0363-01 1 in 1 CARTON 08/25/2023 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 Drug M017 08/25/2023 Labeler - Walgreens (008965063) Registrant - Unipack LLC (116015769) Establishment Name Address ID/FEI Business Operations Unipack LLC 009248480 manufacture(0363-0363)