BIINI HAND SANITIZER- isopropyl alcohol gel

BiiNi Hand Sanitizer by

Drug Labeling and Warnings

BiiNi Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Biini, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Isopropyl Alcohol 75% v/v Purpose Antiseptic

PURPOSE

Antiseptic

INDICATIONS & USAGE

Hand sanitizer to help reduce bacteria that potentially can cause diseases

WARNINGS

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

DO NOT USE

• on open skin wounds
• in children less than 2 months of age

WHEN USING

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

INACTIVE INGREDIENT

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

STORAGE AND HANDLING

• store between 15-30C (59-86F)
• avoid freezing and excessive heat above 40C (104F)

DOSAGE & ADMINISTRATION

• place enough product on hands to cover all surfaces and rub together until dry
• supervise children under 6 years of age when using product to avoid swallowing

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.

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

INGREDIENTS AND APPEARANCE

BIINI HAND SANITIZER 
isopropyl alcohol gel

Product 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)