Label: HEALERZ FOR NOSES- benzalkonium chloride and lidocaine hydrochloride 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 May 10, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Benzalkonium Chloride 0.13%First Aid Antiseptic
    Lidocaine HCl 0.5%Pain Relieving Cream
  • Uses

    First aid to help prevent skin infection and for the temporary relief of pain in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

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

    Do not use

    • in eyes
    • in large quantities
    • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
    • for more than one week unless directed by a doctor

    Stop use and ask a doctor if

    • the condition gets worse
    • condition clears up and recurs within a few days
    • condition persists for more than 7 days
  • Directions

    • adults and children 2 years and older: clean affected area, apply small amount not more than 3 to 4 times daily
    • children under 2 years: do not use, consult a doctor
  • Other Information

    • store at room temperature (do not freeze)
    • Do not use any opened or torn packets
  • Inactive Ingredients

    aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

  • SPL UNCLASSIFIED SECTION

    Distributed By
    WellcoBrands
    Buffalo, NY 14221

  • PRINCIPAL DISPLAY PANEL - 0.5 g Packet Box

    Healerz™
    ... For Noses

    Chapped Skin Relief with Pain Reliever

    Antiseptic / Pain Relief Cream

    6Packets 0.018 oz (0.5g) each

    Principal Display Panel - 0.5 g Packet Box
  • INGREDIENTS AND APPEARANCE
    HEALERZ FOR NOSES 
    benzalkonium chloride and lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50485-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50485-101-016 in 1 BOX
    10.5 g in 1 PACKET
    2NDC:50485-101-0224 in 1 BOX
    20.5 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A11/01/2012
    Labeler - Wellco Brands LLC (078463203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(50485-101)
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