Label: PIRANHA BRAND FOAMING ANTIBACTERIAL HAND- foaming antibacterial hand soap 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

    Triclosan 0.5% w/w.......Antibacterial Agent

  • INACTIVE INGREDIENT

    Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Glycerin, Polyquaternium-7, Aloe Barbadensis Leaf, Tocopheryl Acetate, Disodium Cocamido MIPA-Sulfosuccinate, Tetrasodium EDTA, Fragance, Citric Acid, Polyquaternium-10, DMDM Hydantoin, Yellow 5, Red 33. 

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    For external use only.

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

    Stop use and ask a doctor if, in rare instances, redness or irritation develop and persists for more than 72 hours.

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

  • PURPOSE

    For handwashing to decrease bacteria on skin.

  • DOSAGE & ADMINISTRATION

    To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on skin.

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

    Stop use and ask a doctor if, in rare instances, redness or irritation develop and persists for more than 72 hours.

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

  • PRINCIPAL DISPLAY PANEL

    61625-689-41.jpg  61625-689-41.jpg

  • INGREDIENTS AND APPEARANCE
    PIRANHA BRAND FOAMING ANTIBACTERIAL HAND 
    foaming antibacterial hand soap with aloe and vitamin e solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61625-689
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN18.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61625-689-411000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2013
    Labeler - Bio Shine, Inc. (801231184)
    Registrant - Kutol Products Company, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(61625-689) , analysis(61625-689) , label(61625-689) , pack(61625-689)
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