SHSNH6-4621- ethyl alcohol gel

SHSNH6-4621 by

Drug Labeling and Warnings

SHSNH6-4621 by is a Otc medication manufactured, distributed, or labeled by Shotwell Hydrogenics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients(s)

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Use(s)

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

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 for a doctor if irritation 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.

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

Other information

Store between 15-30C(59-86F)

Avoid freezing and excessive heat above 40C(104F)

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

Antiseptic Gel

Topical Solution

With Vitamin E

Packaging

INGREDIENTS AND APPEARANCE

SHSNH6-4621 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73870-562
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73870-562-33	1249 L in 1 CONTAINER; Type 0: Not a Combination Product	10/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/05/2020

Labeler - Shotwell Hydrogenics, LLC (108985732)

Establishment
Name	Address	ID/FEI	Business Operations
Shotwell Hydrogenics, LLC		108985732	manufacture(73870-562)