Label: ACURE HAND SANITIZER- alcohol gel

  • NDC Code(s): 54136-007-05
  • Packager: Better Planet Brands LLC
  • 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 27, 2020

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

  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

    Purpose

    Antimicrobial

  • Uses

    Hand sanitizer to help 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 the 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

    • Put enough product in your palm to cover hands and rub hands together until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    Store below 110˚F (43˚C). May discolor certain fabric surfaces.

  • Inactive ingredients

    WATER/AQUA, GLYCERIN, ALOE BARBADENSIS LEAF JUICE, CARBOMER, AMIDOMETHYL PROPANOL.

  • Questions?

    Call toll-free 877.902.2873

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ACURE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54136-007
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54136-007-05147 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2020
    Labeler - Better Planet Brands LLC (960253719)