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Healerz for Itches (Wellco Brands LLC)

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Dosage Form Package Information Links
CREAM 6 PACKET in 1 BOX (50485-102-01) > .5 g in 1 PACKET Label Information

Complete Healerz for Itches Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredient

    Hydrocortisone 1.0%


  • Purpose

    Anti-itch


  • 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

  • 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.


  • Directions

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

  • Other Information

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

  • Inactive Ingredients

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


  • SPL UNCLASSIFIED SECTION

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


  • PRINCIPAL DISPLAY PANEL - 6 Packet Carton

    Healerzâ„¢
    ...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

  • INGREDIENTS AND APPEARANCE
    HEALERZ FOR ITCHES 
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50485-102
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    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)