Drug Labeling and Warnings

Drug Details [pdf]

ETHYL ALCOHOL - alcohol gel 
GOJO Industries, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Directions

• Put a small amount in your palm and rub hands together briskly until dry
• Children under 6 years of age should be supervised when using PURELL

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Warnings
Flammable. Keep away from fire or flame.For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

ETHYL ALCOHOL  
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21749-967
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.70 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-967-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/26/2010
2	NDC: 21749-967-12	354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/26/2010
3	NDC: 21749-967-97	700 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2010
4	NDC: 21749-967-89	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/26/2010	05/30/2019

Labeler - GOJO Industries, Inc. (004162038)

Registrant - GOJO Industries, Inc. (004162038)

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc.		036424534	manufacture(21749-967)

Revised: 12/2018

Document Id: 21ab42df-a778-468b-be5c-34a9d65d226c

34390-5

Set id: f138515e-a5fb-4119-982f-0a2a75aa5192

Version: 5

Effective Time: 20181205