PURELL HEALTHCARE ADVANCED HAND SANITIZER FOAM- alcohol liquid
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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PURELL Healthcare Advanced Hand Sanitizer Foam

Active ingredient

Ethyl Alcohol 70%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin that could cause disease

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.

Directions

Place enough product in your palm to thoroughly cover your hands.

Rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

Other information

Store below 110oF (43oC)

May discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, PEG-12 Dimethicone, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Fragrance (Parfum)

Product Label

PURELL HEALTHCARE ADVANCED HAND SANITIZER FOAM
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-811
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Isopropyl Alcohol (UNII: ND2M416302)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
Caprylyl Glycol (UNII: 00YIU5438U)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-811-45	450 mL in 1 PACKAGE; Type 0: Not a Combination Product	11/01/2018
2	NDC:21749-811-53	535 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/05/2017
3	NDC:21749-811-89	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/05/2017
4	NDC:21749-811-80	800 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/05/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/05/2017

Labeler - GOJO Industries, Inc. (004162038)

Registrant - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-811)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	manufacture(21749-811) , label(21749-811) , pack(21749-811)