Label: HEALERZ FOR ITCHES- 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 January 9, 2013

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  • 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

    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
  • INGREDIENTS AND APPEARANCE
    HEALERZ FOR ITCHES 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50485-102
    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
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50485-102-016 in 1 BOX
    10.5 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34802/01/2013
    Labeler - Wellco Brands LLC (078463203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(50485-102)
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