Label: SKIN A COOL HYDROCORTISONE ANTI-ITCH- hydrocortisone cream

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

Drug Label Information

Updated November 10, 2023

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  • DRUG FACTS:

  • Active Ingredients:

    Hydrocortisone 1.0%

    Purpose

    Anti-itch

  • Uses:

    • Temporary relief of skin itching.
    • The temporary relief of itching associated with minor skin irritations and rashes.
    • Other uses of this product should be only under the advise and supervision of a doctor.
  • Warnings:

    For external use only.

    Do not use for

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

    When using this product

    • Avoid contact with the eyes.
    • Do not exceed the recommended daily dosage unless directed by a doctor.
    • In case of bleeding, consult a doctor promptly. 
    • Do not put this product into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if

    • condition worsens, or if 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 hydrocorstisone product unless you have consulted a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older:

    Do not use, consult a doctor. Children under 2 years of age:

    When practical, cleanse the affected area "(selected one or both of the following: with mild soap and warm water and rinse thoroughly". or "by patting or blotting with an appropriate cleansing pad").: Adults:

    consult a doctor. Children under 12 years of age:

  • Other Information:

    Store at 20-25°C (68-77°F)

  • Inactive ingredients:

    Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, ceteareth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.

  • Questions?

    visit: skin-a-cool.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SKIN A COOL HYDROCORTISONE ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70288-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70288-173-0056.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2021
    Labeler - Ana-Cool, LLC (091452072)
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