All Hands Co. Hand Sanitizer

Manufacturer
Specified Coating Technologies LLC
Effective date
2020-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:21

Label at a glance#

ProductAll Hands Co. Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub until dry.

Storage and handling

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.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if

Irritation and redness persist.

OTC - STOP USE SECTION

Stop use and ask a doctor if

Irritation or redness persist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub until dry.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerine

Hydrogen Peroxide

Water

OTC - QUESTIONS SECTION

Questions/ Comments

Call 616-216-6395

Monday-Friday 8:00am-5:00pm EST

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4oz 119mL NDC: 77163-616-04 Small Packaging

NDC: 77163-616-04 Small labelNDC: 77163-616-04 Small label

6oz 179mL NDC: 77163-616-06 Small Packaging

NDC: 77163-616-06 Small labelNDC: 77163-616-06 Small label

1/2 Gallon 1.89L NDC: 77163-616-64 Small Packaging

NDC: 77163-616-64 Retail front labelNDC: 77163-616-64 Retail front labelNDC: 77163-616-64 Drug Facts back labelNDC: 77163-616-64 Drug Facts back label

1 Gallon 3.78L NDC: 77163-616-01 Small Packaging

NDC: 77163-616-01 Retail Front LabelNDC: 77163-616-01 Retail Front LabelNDC: 77163-616-01 Drug Facts back labelNDC: 77163-616-01 Drug Facts back label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77163-616-01All Hands Co. Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICLIQUID37851
77163-616-04All Hands Co. Hand Sanitizer119 mL in 1 BOTTLE, SPRAYLIQUID1191
77163-616-06All Hands Co. Hand Sanitizer179 mL in 1 BOTTLE, SPRAYLIQUID1791
77163-616-64All Hands Co. Hand Sanitizer1893 mL in 1 BOTTLE, PLASTICLIQUID18931

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77163-616ALL HANDS CO. HAND SANITIZER (ALCOHOL) LIQUID [SPECIFIED COATING TECHNOLOGIES LLC]1Legacy NDC, 4 package rows20200502_a499616b-1112-4683-e053-2a95a90abb1e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77163-61677163-616-04, 77163-616-06, 77163-616-64, 77163-616-01

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 · Source PDF

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
a49951b8-2001-7286-e053-2995a90a6c94a499616b-1112-4683-e053-2a95a90abb1e2020-05-01WarningsExact identifier
spl id: a49951b8-2001-7286-e053-2995a90a6c94
spl set id: a499616b-1112-4683-e053-2a95a90abb1e

Reported adverse events (FAERS/openFDA)#

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