Label: HYDROCORTISONE- cool relief gel with aloe gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 25, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredients

    Hydrocortisone 1%

  • Drug Facts

    Purpose : Anti-itch

  • 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

    Warnings: For external use only

  • Do not use

    Do not use

    ■ in the genital area if you have a vaginal discharge. Consult a doctor.

    ■ for the treatment of diaper rash. Consult a doctor.

  • When using this product

    When using this product

    ■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

  • Stop use and ask a doctor if

    Stop use and ask a doctor if ■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. ■ rectal bleeding occurs

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

  • 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:

    Aloe extract, ascorbic acid, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, chamomile extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, PEG-40 stearate, petrolatum, purified water, sd 40 alcohol, vitamin A, vitamin D and vitamin E

  • SAFE HANDLING WARNING

    TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

  • Cool Relief Gel 1oz Tube

    Tube Label

  • Cool Relief Gel 1oz

    Carton Label

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    cool relief gel with aloe gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0363
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0363-011 in 1 CARTON08/25/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/25/2023
    Labeler - Walgreens (008965063)
    Registrant - Unipack LLC (116015769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(0363-0363)