Hand Sanitizer 70% Gel by Navajo Manufacturing Company Inc. / Marquis Extraction Technology LLC Hand Sanitizer Gel 70%

Hand Sanitizer 70% Gel by

Drug Labeling and Warnings

Hand Sanitizer 70% Gel by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc., Marquis Extraction Technology LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER 70% GEL- alcohol gel 
Navajo Manufacturing Company 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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Hand Sanitizer Gel 70%

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For eternal use only.

Flammable. Keep away from fire or flame.

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 on the skin.

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

Directions

• Place enough product to cover both hands in the palm, and rub hands together until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store between 59-86°F (15-30°C).
• May discolor certain fabrics or surfaces.

Inactive ingredients

acrylate copolymer, aloe, denatonium benzoate, fragrance, glycerin, water.

Questions or comments?

Call 1-800-525-5097

Principal Display Panel

HAND SANITIZER 70% GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-204
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LINALOOL, (+)- (UNII: F4VNO44C09)
CUMINYL ACETALDEHYDE (UNII: WSW8QXE6HG)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-204-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2020
2	NDC: 67751-204-02	236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2020
3	NDC: 67751-204-03	473.1 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2020
4	NDC: 67751-204-04	946.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2020
5	NDC: 67751-204-05	1 in 1 PACKAGE	02/01/2021
5		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 67751-204-06	2 in 1 PACKAGE	02/01/2021
6		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 67751-204-07	1892 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/05/2020	05/01/2022

Labeler - Navajo Manufacturing Company Inc. (091917799)

Registrant - Navajo Manufacturing Company Inc. (136941411)

Establishment
Name	Address	ID/FEI	Business Operations
Marquis Extraction Technology LLC		117496233	manufacture(67751-204)

Revised: 7/2022

Document Id: e32914fa-8c78-8959-e053-2a95a90a64c0

34390-5

Set id: b076c7e3-549e-10c3-e053-2995a90a70c3

Version: 4

Effective Time: 20220706