SHSNH6-4601 Antiseptic Topical Solution HAND SANITIZER With Vitamin E and Aloe

Manufacturer
Shotwell Hydrogenics, LLC
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:21

Label at a glance#

ProductSHSNH6-4601
Active ingredientALCOHOL
Label structure8 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#

Active ingredients(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

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

• on 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 for a doctor if irritation 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 INGREDIENT SECTION

Inactive ingredients deionized water, polyethylene glycol, AMP-acrylates vinyl isodecanoate crosspolymer, aloe barbadensis leaf juice, glycerin, fragrance, tocopheryl acetate (vitamin E acetate)

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73870-961-332022-01-28C16284748780-1d6a99b39-a860-a426-e053-dadaa90af4c2SHSNH6-4601 Antiseptic Topical Solution HAND SANITIZER With Vitamin E and Aloe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73870-961-33SHSNH6-46011249 L in 1 CONTAINERGEL12491

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73870-961SHSNH6-4601 (ETHYL ALCOHOL) GEL [SHOTWELL HYDROGENICS, LLC]1Legacy NDC, 1 package rows20200607_89de0acd-e7ad-42ab-8d20-d0e20d1ca9b3.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73870-96173870-961-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
add62257-2b85-45d9-83e7-c43c1ff8a7c589de0acd-e7ad-42ab-8d20-d0e20d1ca9b32020-06-03WarningsExact identifier
spl id: add62257-2b85-45d9-83e7-c43c1ff8a7c5
spl set id: 89de0acd-e7ad-42ab-8d20-d0e20d1ca9b3

Reported adverse events (FAERS/openFDA)#

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