Label: HAND SANITIZER- 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 June 16, 2020

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  • DIRECTIONS

    Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

  • INACTIVE INGREDIENTS

    Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

  • INDICATIONS AND USAGE

    Use[s]

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • 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.

  • PURPOSE

    Purpose Antmicrobial

  • WARNINGS AND PRECAUTIONS

    Store below 110°F (43°C)

    Avoid freezing and excessive heat above 40C (104F)

    in children less than 2 months of age
    on open skin wounds

  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from heat or flame

  • ACTIVE INGREDIENT

    Active ingredient Ethyl Alcohol 70% v/v…

  • STOP USE AND ASK A DOCTOR

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • PACKAGE LABELS

    LABEL 250 mlLABEL 500 mLLABEL 1000 mLLABEL 4000 mL FINAL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79049-0030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.2922 mL  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.00375 mL  in 1 mL
    TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.00185 mL  in 1 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.0022 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79049-0030-2250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    2NDC:79049-0030-3500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    3NDC:79049-0030-41000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    4NDC:79049-0030-54000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/16/2020
    Labeler - Casillas Tiscareno, María Guadalupe (951579493)
    Registrant - Casillas Tiscareno, María Guadalupe (951579493)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casillas Tiscareno, María Guadalupe951579493manufacture(79049-0030)
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