Label: ODORLESS HAND SANITIZER FOAM- benzalkonium chloride liquid

  • 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 August 23, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For Hand sanitizing to decrease bacteria on the skin

    Recommended for repeated uses

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes. In case of eye contact,flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Aloe Vera*, Vitamin E*, Green Tea Extract*, Dihydroxypropyl PEG-5 Linoleamonium Chloride, Glycereth-2 Cocoate, Behentrimonium Chloride, Dihydroxyethyl Cocamine Oxide.

    *Skin Conditioner

  • PRINCIPAL DISPLAY PANEL

    Tink's

    Odorless Hand

    Sanitizer Foam

    Sanitize your hands after field dressing

    Alcohol Free

    Kills 99.99% of Harmful Germs and Bacteria

    Rinse free formula

    Enriched with moisturizing agents

    tinks69.com

    5 FL. OZ. (150 ML)

    container label

  • INGREDIENTS AND APPEARANCE
    ODORLESS HAND SANITIZER FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52473-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    Glycereth-2 Cocoate (UNII: JWM00VS7HC)  
    Behentrimonium Chloride (UNII: X7GNG3S47T)  
    Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52473-010-05150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2010
    Labeler - Tinks (143048010)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Accessories of Pensacola, Inc.177282936repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Products, Inc157469086manufacture
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