Label: BACIBAN- gel sanitizer 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 August 22, 2020

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

View All Sections
  • Active ingredient

    Active ingredient

    Ethyl Alcohol 80%

    Drug Facts Section

  • Purpose

    Antiseptic, Hand Sanitizer

  • Uses

    Hand sanitizer to help reduce bacteria on the hands

  • Warnings

    For external use only-hands.

    Flammable. Keep away from heat and flame. Do not use in

    children less than 2 months of age on open skin wounds

  • Do Not Use

    • in children less than 2 months of age
    • on open skin wounds
  • When using this product

    Keep out of eyes, ears, and mouth.

    In case of contact with eyes, flush thoroughly with water.

  • Directions

    Place enough product on hands to cover all surfaces.

    Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing

  • Other Information

    •Store between 15-30C

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

    • may discolor some fabrics • harmful to wood finishes and plastics

  • Inactive Ingredients

    Glycerin, Hydrogen Peroxide, Guaraprolose, Citric Acid, Purified Water USP

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help of contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    BaciBan Label

  • INGREDIENTS AND APPEARANCE
    BACIBAN 
    gel sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77330-003(NDC:75682-435)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77330-003-013758 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
    2NDC:77330-003-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
    3NDC:77330-003-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
    4NDC:77330-003-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
    5NDC:77330-003-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
    6NDC:77330-003-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/29/2020
    Labeler - Bonaventura Industries Inc (117514553)
    Registrant - Bonaventura Industries Inc (117514553)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bonaventura Industries Inc117514553relabel(77330-003)
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!