HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Marquis Extraction Technology LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteriaon the skin that potentially can cause disease. For use when soap and water are unavailable

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds
• in eyes

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

acrylates copolymer, alpha tocopherol acetate, Denatonium benzoate, glycerin, isopropyl myristate propylene glycol, triisopropyl amine, fragrance

Package Label - Principal Display Panel

NDC: 76585-004

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76585-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	5 mL  in 100 mL
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	0.005 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.6 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.25 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.75 mL  in 100 mL
TRIISOPROPYLAMINE (UNII: Y67CF9Z56L)	0.875 mL  in 100 mL
CUMINYL ACETALDEHYDE (UNII: WSW8QXE6HG)	0.6 mL  in 100 mL
LINALOOL, (+)- (UNII: F4VNO44C09)	0.6 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76585-004-17	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020
2	NDC: 76585-004-11	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020
3	NDC: 76585-004-13	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020
4	NDC: 76585-004-14	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020
5	NDC: 76585-004-12	1040875 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020
6	NDC: 76585-004-18	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020
7	NDC: 76585-004-15	12113 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020
8	NDC: 76585-004-16	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020
9	NDC: 76585-004-20	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/27/2020

Labeler - Marquis Extraction Technology LLC (117496233)

Establishment
Name	Address	ID/FEI	Business Operations
Marquis Extraction Technology LLC		117496233	manufacture(76585-004)