Label: BIINI HAND SANITIZER- isopropyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 83156-562-02, 83156-562-04, 83156-562-08, 83156-562-16 - Packager: Biini, Inc.
- 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 December 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
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SPL UNCLASSIFIED SECTION
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. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIINI HAND SANITIZER
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83156-562 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.07 mL in 1 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83156-562-08 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/16/2022 2 NDC:83156-562-16 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/16/2022 3 NDC:83156-562-02 59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/16/2022 4 NDC:83156-562-04 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/16/2022 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/16/2022 Labeler - Biini, Inc. (118757471) Registrant - Biini, Inc. (118757471) Establishment Name Address ID/FEI Business Operations Biini, Inc. 118757471 manufacture(83156-562) , label(83156-562) , pack(83156-562)
