BACIBAN HAND SANITIZER- alcohol liquid 
Bonaventura Industries Inc

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.

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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Active ingredient

Ethyl Alcohol 80% ...... Antiseptic, Hand Sanitize

Drug Facts

Purpose

Antiseptic, Hand Sanitizer

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

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

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

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

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

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

Directions

Other information

Inactive ingredients

Purified water, hydrogen
peroxide and Glycerin

Package Label - Principal Display Panel

3.78 L NDC: 77330-001-01

3.78 L Package Label

BACIBAN HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77330-001(NDC:55549-001)
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
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77330-001-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
2NDC:77330-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
3NDC:77330-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
4NDC:77330-001-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
5NDC:77330-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
6NDC:77330-001-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/03/2020
Labeler - Bonaventura Industries Inc (117514553)
Registrant - Bonaventura Industries Inc (117514553)
Establishment
NameAddressID/FEIBusiness Operations
Bonaventura Industries Inc117514553relabel(77330-001)

Revised: 5/2020
Document Id: a502d891-eb14-2e7c-e053-2a95a90a92f7
Set id: a500598f-8de0-6de8-e053-2995a90acb52
Version: 2
Effective Time: 20200506
 
Bonaventura Industries Inc