SHSNH6-4600- ethyl alcohol gel

SHSNH6-4600 by

Drug Labeling and Warnings

SHSNH6-4600 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 70% 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

       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.

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

Packaging

INGREDIENTS AND APPEARANCE

SHSNH6-4600 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73870-960
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73870-960-33	1249 L in 1 CONTAINER; Type 0: Not a Combination Product	06/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020

Labeler - Shotwell Hydrogenics, LLC (108985732)

Establishment
Name	Address	ID/FEI	Business Operations
Shotwell Hydrogenics, LLC		108985732	manufacture(73870-960)