Label: WALGREENS  HYDROCORTISONE PLUS 12 MOISTURIZERS- hydrocortisone cream 

  • Label RSS
  • NDC Code(s): 0363-2063-02, 0363-2063-03, 0363-2063-06
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Hydrocortisone 1%

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  • Purpose

    Anti-itch

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  • Uses

    • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
      • eczema
      • psoriasis
      • poison ivy, oak, sumac
      • insect bites
      • detergents
      • jewelry
      • cosmetics
      • soaps
      • seborrheic dermatitis
    • temporarily relieves external anal and genital itching
    • other uses of this product should only be under the advice and supervision of a doctor
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  • Warnings

    For external use only

    Do not use

    • in the genital area if you have a vaginal discharge. Consult a doctor.
    • for the treatment of diaper rash. Consult a doctor.

    When using this product

    • avoid contact with eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put directly 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
    • rectal bleeding occurs

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

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  • Directions

    • for itching of skin irritation, 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: ask a doctor
    • for external anal and genital itching, adults:
      • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
      • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
      • apply to affected area not more than 3 to 4 times daily
      • children under 12 years of age: ask a doctor
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  • Other information

    • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
    • Store at 20° to 25° C (68° to 77° F)
    • See carton or tube crimp for lot number and expiration date
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  • Inactive Ingredients

    aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    MAXIMUM STRENGTH

    Hydrocortisone Cream 1%
    Plus 12 Moisturizers
    Anti-Itch Cream Enriched With Vitamins

    Well at
    Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    NET WT 1 OZ (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    WALGREENS   HYDROCORTISONE PLUS 12 MOISTURIZERS
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-2063
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (Hydrocortisone) Hydrocortisone 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    cetostearyl alcohol  
    sodium lauryl sulfate  
    sodium cetostearyl sulfate  
    chamomile flower oil  
    citric acid monohydrate  
    corn oil  
    glycerin  
    glyceryl monostearate  
    isopropyl palmitate  
    maltodextrin  
    methylparaben  
    mineral oil  
    paraffin  
    petrolatum  
    propylene glycol  
    propylparaben  
    water  
    stearyl alcohol  
    Vitamin A palmitate  
    cholecalciferol  
    .alpha.-tocopherol acetate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-2063-02 1 in 1 CARTON
    1 28.4 g in 1 TUBE
    2 NDC:0363-2063-06 1 in 1 CARTON
    2 45 g in 1 TUBE
    3 NDC:0363-2063-03 1 in 1 CARTON
    3 60 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 10/03/1989
    Labeler - Walgreen Company (008965063)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(0363-2063)
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