Purell (Alcohol) Gel [Navajo Manufacturing Company Inc.] -

PURELL (ALCOHOL) GEL [NAVAJO MANUFACTURING COMPANY INC.]
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NDC	67751-188-01, 67751-188-02
Set ID	969b2968-8497-4125-949a-6be39b132edb
Category	HUMAN OTC DRUG LABEL
Packager	Navajo Manufacturing Company Inc.
Generic Name
Product Class
Product Number
Application Number	PART333A

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Drug Facts
Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial
Uses
- Hand sanitized 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
- Put enough product in your palm to cover hands and rub hands together briskly until dry
- Children under 6 years of age should be supervised when using this product
Other information
- Store below 110°F (43°C)
- May discolor certain fabrics or surfaces
Inactive ingredients

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

1-888-4-PURELL www.PURELL.com
Purell, 1oz
Purell, 2oz

INGREDIENTS AND APPEARANCE

PURELL
alcohol gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 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 (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67751-188-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
2	NDC:67751-188-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017	09/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/04/2017

Labeler - Navajo Manufacturing Company Inc. (091917799)

Registrant - Navajo Manufacturing Company Inc. (091917799)

Name	Address	ID/FEI	Business Operations
Establishment
Navajo Manufacturing Company Inc.		136941411	relabel(67751-188) , repack(67751-188)

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