Label: THERAPLEX AIM ANTI-ITCH MOISTURIZING- hydrocortisone cream

  • NDC Code(s): 82280-478-02, 82280-478-03
  • Packager: THERAPLEX, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 27, 2024

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  • Drug Facts

  • Active Ingredient

    Hydrocortisone 1%

    Purpose

    Anti-Itch

  • Uses

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

    • eczema
    • soaps
    • detergents
    • cosmetics
    • seborrheic dermatitis
    • psoriasis.
    • Other uses of this product should only be under the advice and supervision of a doctor.
  • Warnings

    For external use only

    Do not use

    • for the treatment of diaper rash, consult a doctor.

    When using this product,

    • avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens, symptoms persist more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.

    Keep out of reach of children.

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

    • 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: do not use, ask a doctor.
  • Inactive Ingredients

    Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

  • Other information

    • Store at 20° to 25°C (68° to 77°F)
  • Questions?

    Toll-free number 888-437-2753 For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

  • Package Labeling 2oz:

    Label0

  • Package Labeling 3oz:

    3oz

  • INGREDIENTS AND APPEARANCE
    THERAPLEX AIM ANTI-ITCH MOISTURIZING 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82280-478
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    FERULIC ACID (UNII: AVM951ZWST)  
    OATMEAL (UNII: 8PI54V663Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82280-478-0256.7 g in 1 JAR; Type 0: Not a Combination Product05/06/2024
    2NDC:82280-478-0385 g in 1 JAR; Type 0: Not a Combination Product05/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/06/2024
    Labeler - THERAPLEX, LLC (118005210)
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