FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Community Chemical
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:47:06

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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

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

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

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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

330 gal Hand Sanitizer gel 330 gal Hand Sanitizer330 gal Hand Sanitizer

55 gal Hand Sanitizer liquid 55 gal Hand Sanitizer liquid55 gal Hand Sanitizer liquid

55 gal Hand Sanitizer gel 55 gal Hand Sanitizer gel55 gal Hand Sanitizer gel

1 gal Hand Santizer liquid 1 gal Hand Sanitizer liquid1 gal Hand Sanitizer liquid

1 gal Hand Sanitizer gel 1 gal Hand Sanitizer gel1 gal Hand Sanitizer gel

32 oz Hand Sanitizer liquid 32 oz Hand Sanitizer liquid32 oz Hand Sanitizer liquid

32 oz Hand Sanitizer gel

32 oz Hand Sanitizer gel32 oz Hand Sanitizer gel

8 oz Hand Sanitizer gel 8 oz Hand sanitizer gel8 oz Hand sanitizer gel

8 oz Hand Sanitizer liquid 8 oz Hand Sanitizer liquid8 oz Hand Sanitizer liquid

4 oz Hand Sanitizer liquid

4 oz Hand Sanitizer liquid4 oz Hand Sanitizer liquid

4 oz Hand Sanitizer gel

4 oz Hand Sanitizer gel4 oz Hand Sanitizer gel2 oz Hand Sanitizer gel

2 oz Hand Sanitizer gel2 oz Hand Sanitizer gel

2 oz Hand Sanitizer liquid

2 oz Hand Sanitizer liquid2 oz Hand Sanitizer liquid

32 oz Hand Sanitizer gel NDC 77386-903-14

32 oz Hand Sanitizer liq NDC 77386-903-04

1 gal Hand Sanitizer gel NDC 77386-903-15

1 gal Hand Sanitizer liq NDC 77386-903-05

55 gal Hand Sanitizer gel NDC 77386-903-16

55 gal Hand Sanitizer liq NDC 77386-903-06

330 gal Hand Sanitizer gel NDC 77386-903-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN5
1039339ethanol 0.8 ML/ML Topical SolutionSCD5
1039339ethanol 80 % Topical SolutionSY5

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77386-903-012023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-022023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-032023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-042023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-052023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-062023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-112023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-122023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-132023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-142023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-152023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-162023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0
77386-903-172023-07-28C16284748780-10191ceaa-6759-198a-e063-dbdaa90aec3ea3d3286a-6279-9f12-e053-2995a90a2be0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77386-903-01Hand Sanitizer59 mL in 1 BOTTLELIQUID595
77386-903-02Hand Sanitizer118 mL in 1 BOTTLELIQUID1185
77386-903-03Hand Sanitizer236 mL in 1 BOTTLELIQUID2365
77386-903-04Hand Sanitizer946 mL in 1 BOTTLELIQUID9465
77386-903-05Hand Sanitizer3785 mL in 1 BOTTLELIQUID37855
77386-903-06Hand Sanitizer208198 mL in 1 DRUMLIQUID2081985
77386-903-11Hand Sanitizer59 mL in 1 BOTTLELIQUID595
77386-903-12Hand Sanitizer118 mL in 1 BOTTLELIQUID1185
77386-903-13Hand Sanitizer236 mL in 1 BOTTLELIQUID2365
77386-903-14Hand Sanitizer946 mL in 1 BOTTLELIQUID9465
77386-903-15Hand Sanitizer3785 mL in 1 BOTTLELIQUID37855
77386-903-16Hand Sanitizer208198 mL in 1 DRUMLIQUID2081985
77386-903-17Hand Sanitizer1248185 mL in 1 CONTAINERLIQUID12481855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77386-903HAND SANITIZER (ALCOHOL) LIQUID [COMMUNITY CHEMICAL]5Legacy NDC, 13 package rows20220118_a3d3286a-6279-9f12-e053-2995a90a2be0.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
77386-90377386-903-02, 77386-903-04, 77386-903-05, 77386-903-06, 77386-903-03, 77386-903-12, 77386-903-13, 77386-903-14, 77386-903-15, 77386-903-16, 77386-903-17, 77386-903-01, 77386-903-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
d5cc96b5-2fd4-fe2b-e053-2995a90af06aa3d3286a-6279-9f12-e053-2995a90a2be02022-01-17WarningsExact identifier
spl id: d5cc96b5-2fd4-fe2b-e053-2995a90af06a
spl set id: a3d3286a-6279-9f12-e053-2995a90a2be0

Reported adverse events (FAERS/openFDA)#

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