FDA.reportPublic FDA data

Antiseptic Hand Sanitizer Foam

Manufacturer
US Chemical Corporation
Effective date
2020-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:29

Label at a glance#

ProductAntiseptic Hand Sanitizer Foam
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

• Hand sanitizer to help reduce bacteria on the skin that could cause disease.  Recommended for repeated use.

Dosage and administration

• Place enough product in your palm to thoroughly cover your hands.  Rub hands together briskly until dry. • Children under 6 years of age should be supervised when using this product.

Storage and handling

• Store in a cool, dry place.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62% v/v

Purpose

OTC - PURPOSE SECTION

Antibacterial Agent

Uses

INDICATIONS & USAGE SECTION

• Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame. For external use only.

Avoid contact with eyes. In case of contact, flush with plenty of water.

Stop use and ask a doctor if irritation or rash appears and persists.

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.

EMERGENCY TELEPHONE: 1-866-923-4913

Directions

DOSAGE & ADMINISTRATION SECTION

• Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using this product.

Other Information

STORAGE AND HANDLING SECTION

• Store in a cool, dry place.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

• Water, Glycerin, PEG-10 Dimethicone

SPL UNCLASSIFIED SECTION

Providing Exceptional Quality Since 1962

Distributed by/Distribuido por:

U S Chemical

316 Hart Street · Watertown, WI 53094

www.uschemical.com

Emergency Phone 1-866-923-4913

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61307-105-102022-01-28C16284748780-1d6a99b39-8e33-a426-e053-dadaa90af4c2U S Chemical Antiseptic Hand Sanitizer Foam

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61307-105ANTISEPTIC HAND SANITIZER FOAM (ETHYL ALCOHOL) LIQUID [US CHEMICAL CORPORATION]1Legacy NDC20200622_8dacdbda-cada-43a8-9e36-90f411bc1b74.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
61307-10561307-105-10

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT

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
9de5cb4c-6440-4429-8ff5-243a766e6ce08dacdbda-cada-43a8-9e36-90f411bc1b742020-06-15WarningsExact identifier
spl id: 9de5cb4c-6440-4429-8ff5-243a766e6ce0
spl set id: 8dacdbda-cada-43a8-9e36-90f411bc1b74

Reported adverse events (FAERS/openFDA)#

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