Label: GERM CRUSHER HAND SANITIZER WIPES GERM CRUSHER- hand sanitizer wipes cloth

  • 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 October 23, 2009

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  • PRINCIPAL DISPLAY PANEL

    Container label, 83 mil

  • ACTIVE INGREDIENT

    Active Ingredient                                                                                                          Purpose

    n-alkyl dimethyl benzyl ammonium chloride (0.1%)................................................Antiseptic

    n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)......................................Antiseptic

  • PURPOSE

    Uses

    • For hand washing to decrease bacteria on skin.
    • Recommended for repeated use.
  • WHEN USING

    Warnings

    Flammable, keep away from heat and flame.

    For external use only.

  • WHEN USING

    When using this product

    • do not get into eyes.  If contact occurs rinse eyes thoroughly with water.
  • STOP USE

    Stop use and ask a doctor

    • If irritation arises and persists for more than 72 hours.
  • KEEP OUT OF REACH OF CHILDREN

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

  • WHEN USING

    Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • Children under six years of age should be supervised when using this product.
  • QUESTIONS

    Inactive Ingredients

    Water, Ethanol, Mineral Oil, Isopropyl Myristate, C12-C14 Sec-pareth-5

  • INGREDIENTS AND APPEARANCE
    GERM CRUSHER HAND SANITIZER WIPES  GERM CRUSHER
    hand sanitizer wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49889-1906
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 970 mL
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 970 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M) 20.0 g  in 970 mL
    WATER (UNII: 059QF0KO0R) 78.1 g  in 970 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.3 g  in 970 mL
    MINERAL OIL (UNII: T5L8T28FGP) 0.7 g  in 970 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49889-1906-04 mL in 1 PACKET
    2NDC:49889-1906-1438 mL in 1 CONTAINER
    3NDC:49889-1906-277 mL in 1 PACKAGE
    4NDC:49889-1906-3206 mL in 1 CONTAINER
    5NDC:49889-1906-4619 mL in 1 CONTAINER
    6NDC:49889-1906-51134 mL in 1 CONTAINER
    7NDC:49889-1906-61247 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33310/01/2009
    Labeler - GMS Industrial Supply, Inc. (135056302)
    Registrant - ITW Dymon (103307604)
    Establishment
    NameAddressID/FEIBusiness Operations
    ITW Dymon103307604manufacture
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