Hand Sanitizer

Manufacturer
Barley Creek Associates, L.P.
Effective date
2020-03-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:04:17

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

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

Label contents#

Full prescribing information#

STORAGE AND HANDLING SECTION

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

DESCRIPTION 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.

GENERAL PRECAUTIONS SECTION

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.

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

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

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

OTC - PURPOSE SECTION

Purpose - Antiseptic

Use(s) Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(s) - Alcohol 80% v/v

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.

USE IN SPECIFIC POPULATIONS SECTION

Do not use

In children less than 2 months of age
On open skin wounds

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.

INDICATIONS & USAGE SECTION

Use(s) Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactsDrug FactsAlcohol Antiseptic 80%Alcohol Antiseptic 80%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

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
73995-100-022022-01-28C16284748780-1d6a99b39-ef07-a426-e053-dadaa90af4c2a1bb1c34-384d-3f54-e053-2995a90adc47

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73995-100-02Hand Sanitizer118.29 mL in 1 BOTTLELIQUID118.293

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73995-100HAND SANITIZER (ETHYL ALCOHOL) LIQUID [BARLEY CREEK ASSOCIATES, L.P.]3Legacy NDC, 1 package rows20200330_a1bb1c34-384d-3f54-e053-2995a90adc47.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
73995-10073995-100-02

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
a1dc3e39-92d0-10b5-e053-2995a90ae031a1bb1c34-384d-3f54-e053-2995a90adc472020-03-27WarningsExact identifier
spl id: a1dc3e39-92d0-10b5-e053-2995a90ae031
spl set id: a1bb1c34-384d-3f54-e053-2995a90adc47

Reported adverse events (FAERS/openFDA)#

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