Label: HAND SANITIZER-ANTIBACTERIAL HAND SANITIZER- hand sanitizer gel 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 May 16, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient

    Alcohol 70%

  • Purpose

    Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria on the skin that could cause disease.

  • Warnings

    Flammable, Keep away from fire or flame.

    For External Use only.

  • When Using this product.

    do not use in or near the eyes, in case of contact, rinse throughly with water.

  • Stop Using this product.

    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

    • Place enough product in your palm to throoughly cover your hands. Rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110°F (43°C)
  • Ingredients

    Alcohol, Water, Acrylates(C-10/30 Alkyl Acylate) Crosspolymer, Aloe Vera, Triethanolamine.

  • Package Label - Principal Disaplay Label

    60ml Label236 ml Label

    60 mL NDC: 77968-070-02

    236 mL NDC: 77968-070-01

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER-ANTIBACTERIAL HAND SANITIZER 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77968-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) 0.4 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.4 mL  in 100 mL
    ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) 0.1 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77968-070-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    2NDC:77968-070-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/11/2020
    Labeler - Consumer Health and Safety Products (968636246)