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Natureplex Hydrocortisone (Natureplex, LLC)

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CREAM 28 g in 1 TUBE (67234-010-01) Label Information

Complete Natureplex Hydrocortisone Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Hydrocortisone 1%


  • Purpose

    Antipruritic (anti-itch)


  • Uses

    • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry
    • and for external anal and genital itching

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Do Not Use
    • if you have a vaginal discharge. Consult a doctor.

    When using this product
    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put into the rectum by using fingers or any mechanical device or applicator

    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
    • beeding occurs

    If pregnant or breast-feeding, ask a health professional before use.

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


  • Directions

    For itching associated with minor skin irritations, 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: Consult a doctor

    For external anal and genital itching:

    Adults and children 12 years of age and older:

    • when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • apply to affected area not more than 3 to 4 times daily

    Children under 12 years of age: Consult a doctor


  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

  • Inactive ingredients

    aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA


  • Questions or comments?

    866-323-0107 or www.natureplex.com


  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Natureplexâ„¢
    MAXIMUM STRENGTH

    Hydrocortisone Cream

    Fast Itch And Rash Relief!

    NET WT. 1 Oz. (28g)

    Principal Display Panel - 28 g Tube Carton

  • INGREDIENTS AND APPEARANCE
    NATUREPLEX HYDROCORTISONE  HYDRO
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 0.01 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    cetyl alcohol (UNII: 936JST6JCN)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    propylparaben (UNII: Z8IX2SC1OH)  
    stearic acid (UNII: 4ELV7Z65AP)  
    trolamine (UNII: 9O3K93S3TK)  
    edetate trisodium (UNII: 420IP921MB)  
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67234-010-01 28 g in 1 TUBE; Type 0: Not a Combination Product 01/22/2008
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/22/2008
    Labeler - Natureplex, LLC (062808196)
    Establishment
    Name Address ID/FEI Business Operations
    Natureplex, LLC 062808196 manufacture(67234-010)