Alcohol Antiseptic Hand Sanitizer 80%

Manufacturer
KBKK LLC dba Nine Band Brewing Company
Effective date
2020-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:21:37

Label at a glance#

ProductAlcohol Antiseptic Hand Sanitizer 80%
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

OTC - PURPOSE SECTION

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nine Band

Brewing Co

Hand Sanitizer

Made in Allen, Texas

Not for Consumption

Alcohol Antiseptic 80%

Topical Solution Hand Sanitizer

Non-Sterile Solution

33.8 Fl Oz (1000 ML)

Final Label 1000MLFinal Label 1000ML

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77026-00177026-001-01, 77026-001-02, 77026-001-03, 77026-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
aaa671c2-38a8-896b-e053-2a95a90a0716aa05bc6c-3590-9748-e053-2995a90a6c2c2020-07-17WarningsExact identifier
spl set id: aa05bc6c-3590-9748-e053-2995a90a6c2c

Reported adverse events (FAERS/openFDA)#

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