Label: QUIK WIPES- advanced hand sanitizing wipes swab

  • 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 September 8, 2009

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  • ACTIVE INGREDIENT

    Active Ingredients                     Purpose

    Ethyl Alcohol 62 percent           Antimicrobial

    Triclosan 0.3 percent                Antimicrobial

  • PURPOSE

    Uses     For hand washing to decrease bacteria on the skin that may cause disease.

    Recommended for repeat use.

  • WARNINGS AND PRECAUTIONS

    Warning Directions

    For external use only. Flammable.

    Keep away from heat and flame. When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

  • STOP USE

    Stop use and ask doctor if irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Directions    Wipe hands thoroughly with product and allow to dry.

    For children under 6, use only under adult supervision.

    Not recommended for infants

  • USER SAFETY WARNINGS

    Do not store above 105 degrees F.

    May discolor some fabrics.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Isopropyl Alcohol, Perfume, Methylparaben, Glycerin, Propylene Glycol,

    Tertiary Butyl Alcohol, Aloe Vera Gel, Tocopheryl Acetate, Denatonium Benzonate

  • PRINCIPAL DISPLAY PANEL

    Cinogen QuikWipes

  • INGREDIENTS AND APPEARANCE
    QUIK WIPES 
    advanced hand sanitizing wipes swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41900-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.003 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41900-400-0120 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33309/05/2009
    Labeler - Cinogen Cosmetics Zhaoqing, LTD. (527929812)
    Registrant - Cinogen Cosmetics Zhaoqing, LTD. (527929812)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cinogen Cosmetics Zhaoqing, LTD.527929812manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Nupak LLC826963550import
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