Label: KERA HC- hydrocortisone cream

  • NDC Code(s): 44577-623-02
  • Packager: Clinical Therapeutic Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • KERA HC Cream Hydrocortisone 1%


  • Active Ingredient

    Hydrocortisone-USP 1.00%

  • Purpose

    Anti-Itch

  • Uses:

    Temporarily relieves itching associated with minor skin irritations, inflammations and rashes due to:

    • Excessively Dry Skin, Eczema, Insect Bites, Poison Ivy, Oak or Sumac, Soaps, Detergents, Cosmetics, Jewelery, Seborrheic Dermatitis, Psoriasis
    • Other uses of this product should only be under the advice and supervisor of a doctor
  • Warnings

    • For external use only
  • When using this product:

    • Avoid contact with eyes
    • Do not use more than directed unless told to do so by a doctor
  • Stop use and ask a doctor if:

    • Condition worsens or symptoms persist for more than 7 days, or if symptoms clear up, and then return
  • Keep out of reach of children.

    If swallowed, contact physician or poison control center immediately.


  • Store at room temperature (20-25 degrees C) (68-77 degrees F)


  • Directions:

    For itching of skin irritation, inflammation and rashes:

    • Apply to affected area not more than 3 to  4 times daily.
    • Not for use by children under 2 years of age

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), C12-15 Alkyl Benzoate, c13-14 Isoparaffin, Ethylhexylglycerin, Glycerin, Heilianthus Annuus (Sunflower) Seed Oil, Laureth-7, Phenoxyethanol, Polacrylamide, Polysorbate-20, Tocopheryl Acetate (Vitamin E), Urea-USP.

  • Distributed By:

    Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719  www.CTSRX.com

  • KERA HC Cream Hydrocortisone 1% 2oz/56g (44577-623-02)

    KERAHC

  • INGREDIENTS AND APPEARANCE
    KERA HC 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-623
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44577-623-0256 g in 1 TUBE; Type 0: Not a Combination Product02/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/17/2012
    Labeler - Clinical Therapeutic Solutions (078402750)
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