BiiNi Hand Sanitizer

Manufacturer
Biini, Inc.
Effective date
2022-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:52:32

Label at a glance#

ProductBiiNi Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v Purpose Antiseptic

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause diseases

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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 SECTION

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

OTC - STOP USE SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT SECTIONACTIVE INGREDIENT SECTION

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN2
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD2
581698isopropyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83156-562-02BiiNi Hand Sanitizer59 mL in 1 BOTTLE, DISPENSINGGEL592
83156-562-04BiiNi Hand Sanitizer118 mL in 1 BOTTLE, DISPENSINGGEL1182
83156-562-08BiiNi Hand Sanitizer237 mL in 1 BOTTLE, PUMPGEL2372
83156-562-16BiiNi Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83156-562BIINI HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [BIINI, INC.]2Legacy NDC, 4 package rows20221217_eff605ba-3197-32c9-e053-2995a90a4557.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83156-56283156-562-08, 83156-562-16, 83156-562-02, 83156-562-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eff659b0-90ec-8132-e053-2995a90a2608eff605ba-3197-32c9-e053-2995a90a45572022-12-16WarningsExact identifier
spl id: eff659b0-90ec-8132-e053-2995a90a2608
spl set id: eff605ba-3197-32c9-e053-2995a90a4557

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.