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 Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria 0n the skin that potentially can cause disease. For use when soap and water are not available.

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

acrylate copolymer, aloe, alpha-tocopheral acetate, denatonium benzoate, fragrance, glycerin, purified water USP

Package Label - Principal Display Panel

Gel 007

INGREDIENTS AND APPEARANCE

MARQUIS GEL FORMULA 
marquis gel formula gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76585-007
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.05 mL  in 100 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)	0.00035 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.75 mL  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.05 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	1.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76585-007-17	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC: 76585-007-11	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC: 76585-007-13	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
4	NDC: 76585-007-14	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
5	NDC: 76585-007-15	12113 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
6	NDC: 76585-007-12	1040875 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
7	NDC: 76585-007-18	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
8	NDC: 76585-007-16	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
9	NDC: 76585-007-20	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Marquis Extraction Technology LLC (117496233)

Establishment
Name	Address	ID/FEI	Business Operations
Marquis Extraction Technology LLC		117496233	manufacture(76585-007)