Label: BACIBAN- gel sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77330-002-01, 77330-002-02, 77330-002-04, 77330-002-08, view more77330-002-16, 77330-002-32 - Packager: Bonaventura Industries Inc
- This is a repackaged label.
- Source NDC Code(s): 55549-002
- 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 12, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do Not Use
- When using this product
- Directions
- Other Information
- Inactive Ingredients
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BACIBAN
gel sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77330-002(NDC:55549-002) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:77330-002-01 3758 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2020 2 NDC:77330-002-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2020 3 NDC:77330-002-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2020 4 NDC:77330-002-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2020 5 NDC:77330-002-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2020 6 NDC:77330-002-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/05/2020 Labeler - Bonaventura Industries Inc (117514553) Registrant - Bonaventura Industries Inc (117514553) Establishment Name Address ID/FEI Business Operations Bonaventura Industries Inc 117514553 relabel(77330-002)