BIINI HAND SANITIZER- isopropyl alcohol gel 
Biini, 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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Isopropyl Alcohol 75% v/v Purpose Antiseptic

Antiseptic

Hand sanitizer to help reduce bacteria that potentially can cause diseases

For external use only. Not intended for ingestion. Flammable. Keep away from fire or flame.

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

glycerin, lemon fragrance, PEG-6 AMP-acrylates/ vinyl isodecanoate crosspolymer, purified water USP

If swallowed, get medical help or contact a Poison Control Center right away.

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

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:

Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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 SECTION

BIINI HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83156-562
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.07 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LEMON (UNII: 24RS0A988O)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83156-562-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/16/2022
2NDC:83156-562-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/16/2022
3NDC:83156-562-0259 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/16/2022
4NDC:83156-562-04118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/16/2022
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/16/2022
Labeler - Biini, Inc. (118757471)
Registrant - Biini, Inc. (118757471)
Establishment
NameAddressID/FEIBusiness Operations
Biini, Inc.118757471manufacture(83156-562) , label(83156-562) , pack(83156-562)

Revised: 12/2022
Document Id: eff659b0-90ec-8132-e053-2995a90a2608
Set id: eff605ba-3197-32c9-e053-2995a90a4557
Version: 2
Effective Time: 20221216
 
Biini, Inc.