PURELL HEALTHCARE ADVANCED HAND SANITIZER GEL- 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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PURELL Healthcare Advanced Hand Sanitizer Gel

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin

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 product on hands
Rub until dry

Inactive ingredients

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

Product Label

PURELL HEALTHCARE ADVANCED HAND SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-716
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-716-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2017
2	NDC:21749-716-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2017
3	NDC:21749-716-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2017
4	NDC:21749-716-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2017
5	NDC:21749-716-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2017
6	NDC:21749-716-89	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2017
7	NDC:21749-716-20	2000 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/15/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/15/2017

Labeler - GOJO Industries, Inc. (004162038)

Registrant - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	MANUFACTURE(21749-716)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	MANUFACTURE(21749-716) , label(21749-716) , pack(21749-716)