SHSNH6-3601 Antiseptic Gel HAND SANITIZER

Manufacturer: Shotwell Hydrogenics, LLC
Effective date: 2021-04-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:39:37

Label at a glance#

ProductSHSNH6-3601

Active ingredientISOPROPYL ALCOHOL

Label structure9 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

Isopropyl 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
• in children less than 2 years 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 ingredients

INACTIVE INGREDIENT SECTION

deionized water, polyethylene glycol, AMP-acrylates vinyl isodecanoate crosspolymer, glycerin, fragrance

SPL UNCLASSIFIED SECTION

Topical Solution

HAND SANITIZER

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHSNH6-3601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581698	isopropyl alcohol 70 % Topical Gel	PSN	2
581698	isopropyl alcohol 0.7 ML/ML Topical Gel	SCD	2
581698	isopropyl alcohol 70 % Topical Gel	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73870-516-16	2022-07-29	C162847	48780-1	e4f33bdf-ad0e-d8a0-e053-dadaa90a6e4e	SHSNH6-3601 Antiseptic Gel HAND SANITIZER
73870-516-33	2022-07-29	C162847	48780-1	e4f33bdf-ad0e-d8a0-e053-dadaa90a6e4e	SHSNH6-3601 Antiseptic Gel HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73870-516-16	SHSNH6-3601	0.5 L in 1 BOTTLE, PUMP	GEL	0.5		2
73870-516-33	SHSNH6-3601	1249 L in 1 CONTAINER	GEL	1249		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73870-516	SHSNH6-3601 (ISOPROPYL ALCOHOL) GEL [SHOTWELL HYDROGENICS, LLC]	2	Legacy NDC, 2 package rows	20210413_7c1e86fd-950a-48d4-858f-b4bda3968758.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

SHSNH6-3601
Isopropyl Alcohol
WATER
POLYETHYLENE GLYCOL, UNSPECIFIED
AMINOMETHYLPROPANOL
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73870-516	73870-516-33, 73870-516-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ISOPROPYL ALCOHOL	ND2M416302	ACTIB
WATER	059QF0KO0R	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)	2N8MDB79NA	IACT
GLYCERIN	PDC6A3C0OX	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6bec072d-7bc6-4628-be38-9c661fdd05e4			7c1e86fd-950a-48d4-858f-b4bda3968758	2021-04-09	Warnings	Exact identifier spl id: 6bec072d-7bc6-4628-be38-9c661fdd05e4 spl set id: 7c1e86fd-950a-48d4-858f-b4bda3968758

Reported adverse events (FAERS/openFDA)#

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