Marquis Gel Formula by Marquis Extraction Technology LLC MARQUIS GEL FORMULA gel

Marquis Gel Formula by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Alcohol 70% v/v

Purpose Antiseptic

Purpose

Antiseptic

Stop use and ask a doctor if

irritation or rash occurs. These may be signs of a serious condition.

Use

Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease.

For use when soap and water are unavailable.

Warnings

For external use only.

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 this product

keep out of eyes, ears, and mouth

in case of contactwith eyes, rinse eyes thoroughly with water

Kep 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 age 6 when using this product to avoid swallowing.

Other Information

Store between 59-86 F (15-30C)

Avoid freezing and excessive heat above 104F (40C)

Inactive Ingredients

acrylate copolymer, aloe, denatonium benzoate, fragrance, propylene glycol, water

Package Label

Gel 010

INGREDIENTS AND APPEARANCE

MARQUIS GEL FORMULA 
marquis gel formula gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76585-010
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)	0.3 mL  in 100 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)	0.00035 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	1.1 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.005 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1 mL  in 100 mL
CUMINYL ACETALDEHYDE (UNII: WSW8QXE6HG)	0.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76585-010-17	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
2	NDC: 76585-010-11	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
3	NDC: 76585-010-13	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
4	NDC: 76585-010-14	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
5	NDC: 76585-010-15	12113 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
6	NDC: 76585-010-12	1040875 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
7	NDC: 76585-010-18	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
8	NDC: 76585-010-16	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
9	NDC: 76585-010-20	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	10/01/2020

Labeler - Marquis XT LLC (117496233)

Establishment
Name	Address	ID/FEI	Business Operations
Marquis XT LLC		117496233	manufacture(76585-010)