Label: HEALERZ FOR ITCHES- hydrocortisone cream 

  • 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Hydrocortisone 1.0%

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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
    • other uses of product should be only under the advice and supervision of a doctor
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  • Warnings

    For external use only.

    Do not use

    • for treatment of diaper rash
    • for feminine itching

    Avoid contact with eyes

    Stop use and ask a doctor

    • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
    • with use of other hydrocortisone products

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

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  • Directions

    • apply to affected area not more than 3 to 4 times daily
    • children under 2 years: ask a doctor
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  • Other Information

    • store at room temperature
    • Do not use any opened or torn packets
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  • Inactive Ingredients

    emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

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  • SPL UNCLASSIFIED SECTION

    Distributed By
    WellcoBrands
    716-568-8040
    Buffalo, NY 14221

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  • PRINCIPAL DISPLAY PANEL - 6 Packet Carton

    Healerz
    ...For Itches

    Fast relief for your scratchy skin

    1% Hydrocortisone Anti-Itch Cream

    6 Packets 0.018 oz (0.5g) each

    Principal Display Panel - 6 Packet Carton
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  • INGREDIENTS AND APPEARANCE
    HEALERZ FOR ITCHES 
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50485-102
    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
    ALCOHOL  
    METHYLPARABEN  
    MINERAL OIL  
    PARAFFIN  
    PETROLATUM  
    PROPYLPARABEN  
    WATER  
    WHITE WAX  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50485-102-01 6 in 1 BOX
    1 0.5 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 02/01/2013
    Labeler - Wellco Brands LLC (078463203)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(50485-102)
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