Label: BACTIVE 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 June 16, 2020

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

View All Sections
  • Active Ingredient(s)

    Ethyl Alcohol 70%.

  • Purpose

    Antiseptic

  • Use

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeat use
  • Warnings

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

  • WHEN USING

    When using this product

    ■ keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    ■ avoid contact with broken skin.

    ■ do not inhale or ingest.

  • STOP USE

    Stop use and ask a doctor

    • If irritation and redness develop.
    • If condition persists for more than 72 hours consult a doctor.
  • 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.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other information

    • Store between 15-30C (59-86F)
    • use within 12 months of opening
    • may discolour some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbedensis leaf extract, aminomethyl propanol, fragrance, glycerin, maltodextrin, water

  • Package Label - Principal Display Panel

    50 mL 50 mL label

    500 mL 500 mL label

    2L 2L label

  • INGREDIENTS AND APPEARANCE
    BACTIVE HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76658-115
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76658-115-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    2NDC:76658-115-092000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/2020
    3NDC:76658-115-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/17/2020
    Labeler - Zuru LLC (080435986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Opal Cosmetics (Huizhou) Limited528178475manufacture(76658-115) , label(76658-115)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!