Label: PIRANHA BRAND ALCOHOL FREE FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E- foaming instant hand sanitizer with aloe and vitamin e solution

  • 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 March 11, 2014

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  • ACTIVE INGREDIENT

    Benzethonium Chloride 0.2% w/w.....Antibacterial Agent

  • INACTIVE INGREDIENT

    Water, Fragrance, Aloe Barbadensis Leaf, Tocopheryl Acetate, Cocamidopropyl Betaine, Propylene Glycol, Phenoxyethanol, PEG-7 Glyceryl Cocoate, Tetrasodium EDTA. 

  • PURPOSE

    Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • WARNINGS

    For external use only.

    Avoid contact with eyes. If contact occurs, flush with water.

    Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • DOSAGE & ADMINISTRATION

    To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

    Avoid contact with eyes. If contact occurs, flush with water.

    Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • PRINCIPAL DISPLAY PANEL

    61625-682-41.jpg  61625-682-41.jpg 

  • INGREDIENTS AND APPEARANCE
    PIRANHA BRAND ALCOHOL FREE FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E 
    foaming instant hand sanitizer with aloe and vitamin e solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61625-682
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE7.56 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61625-682-411000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/17/2013
    Labeler - Bio Shine, Inc. (801231184)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(61625-682) , analysis(61625-682) , label(61625-682) , pack(61625-682)
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