BACIBAN- gel sanitizer gel 
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.

----------

Active ingredient

Active ingredient

Ethyl Alcohol 70%

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

When using this product

Keep out of eyes, ears, and mouth.

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

Stop use and ask a doctor if irritation or rash occurs.

These may be signs of a serious condition.

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

Purified water, Hydrogen Peroxide, Carbomer, and Glycerin

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

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

BaciBan Label

BACIBAN 
gel sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77330-002(NDC:55549-002)
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
WATER (UNII: 059QF0KO0R) 23.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 4 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77330-002-013758 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
2NDC:77330-002-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
3NDC:77330-002-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
4NDC:77330-002-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
5NDC:77330-002-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
6NDC:77330-002-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/05/2020
Labeler - Bonaventura Industries Inc (117514553)
Registrant - Bonaventura Industries Inc (117514553)
Establishment
NameAddressID/FEIBusiness Operations
Bonaventura Industries Inc117514553relabel(77330-002)

Revised: 6/2020
Document Id: a7e35ffe-7405-626d-e053-2995a90a199b
Set id: a7e35ffe-7404-626d-e053-2995a90a199b
Version: 1
Effective Time: 20200612
 
Bonaventura Industries Inc