Label: ON GUARD HAND SANITIZING WIPE- alcohol cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 1, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active Ingredient

    Ethyl alcohol 64%

    Purpose

    Antimicrobial

    Use

    • sanitizing wipes to reduce bacteria on the skin.

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if irritation or rash appears and lasts

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

    Directions

    • tear open, unfold, and apply to hands
    • children under 6 years of age should be supervised when using this product

    Other information

    • store below 110°F (43°C)
    • may discolor certain fabrics or surfaces
    • alcohol derived from corn

    Inactive ingredients

    Water, glycerin, fragrance, On Guard™ essential oil blend, aloe barbadensis leaf extract, polysorbate 20, tocopheryl acetate

    Distributed by dōTERRA Intl, LLC, Orem, UT 84057.
    For customer support, call 800-411-8151.
    993808/103808 Made in Chine
    NOT FOR RESALE IN CANADA
    CPTG Certified Pure Therapeutic Grade™

  • Principal Display Panel – Packet - ONE BIODEGRADABLE WIPE

    On Guard Hand Sanitizing Wipes – Packet
    dōTERRA®
    onGUARD™
    Hand Sanitizing Wipes
    KILLS 99.99% OF GERMS
    ONE BIODEGRADABLE WIPE

    Principal Display Panel – Packet - ONE BIODEGRADABLE WIPE
  • Principal Display Panel – Carton - 20 BIODEGRADABLE WIPES

    On Guard Hand Sanitizing Wipes – Carton
    doōTERRA®
    onGUARD™
    Hand Sanitizing Wipes
    KILLS 99.99% OF GERMS
    20 BIODEGRADABLE WIPES
    Individually Wrapped 5” x 7” (12.7 x 17.8 cm)

    Principal Display Panel – Carton - 20 BIODEGRADABLE WIPES
  • INGREDIENTS AND APPEARANCE
    ON GUARD HAND SANITIZING WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49924-1231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.8 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 96 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 870.4 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49924-1231-120 in 1 CARTON
    11 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35811/01/2009
    Labeler - do Terra (832274935)
    Registrant - Nox Bellcow (528103343)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nox-Bellcow528103343MANUFACTURE
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