Otc - Active Ingredient
Isopropyl Alcohol 75% v/v Purpose Antiseptic
Biini Hand Sanitizer
FDA Label NDC 83156-562
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biini, Inc. for the product Biini Hand Sanitizer (NDC 83156-562). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, inactive ingredient, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - Do Not Use
- on open skin wounds
- in children less than 2 months of age
Otc - 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
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Other
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.
* Please review the disclaimer below.
