Label: THERAPLEX AIM ANTI-ITCH MOISTURIZING CREAM- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 17, 2019

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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

  • SPL UNCLASSIFIED SECTION

    NON STINGING

    For Maximum Strength Relief of Rashes & Itching Flare-Ups Caused by
    • Eczema • Psoriasis • Seborrheic Dermatitis

    NEW

    Stops the itch of Eczema quickly

    • Helps repair and restore the skin’s natural protective barrier

    • Promotes healthy skin flora

    • Contains natural coconut oil to soothe and moisturize the skin

    • Instantly penetrates into the skin's surface

    • NO preservatives, parabens, fragrances, lanolin, or gluten

    • Not tested on animals

    • Non-stinging

    • Patent Pending

    www.theraplex.com

    Dist. By The Theraplex Company, LLC, Memphis, TN 38119

  • Packaging

    Therplx3

  • INGREDIENTS AND APPEARANCE
    THERAPLEX  AIM ANTI-ITCH MOISTURIZING CREAM
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62917-819
    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
    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:62917-819-031 in 1 CARTON08/15/2019
    185 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/15/2019
    Labeler - The Theraplex Company, LLC (363529392)
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