Label: ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel

  • 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 July 18, 2016

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  • ACTIVE INGREDIENT

    Active ingredients
    Alcohol 63%

  • PURPOSE

    Purpose
    Antiseptic Hand Sanitizer

  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from fire or flame

    Alcohol is used

    Do not use in the eyes. If this happens, rinse thoroughly with water.

    In case of deep or puncture wounds, consult your doctor

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops 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

  • DOSAGE & ADMINISTRATION

    Directions

    Liberally spray on skin and gently massage until absorbed

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadenis Leaf, Fragrance, Carbomer

  • INDICATIONS & USAGE

    Uses

    to decrease bacteria on the skin

  • PRINCIPAL DISPLAY PANEL

    image of bottle labelimage of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70611-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70611-003-039.7 mL in 1 BOTTLE; Type 0: Not a Combination Product07/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/18/2016
    Labeler - Yoyo Lip Gloss Inc. (828881792)
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