SUEZ Gel Formula by SUEZ Water Technologies & Solutions / Marquis Extraction Technology LLC SUEZ GEL FORMULA gel

SUEZ Gel Formula by

Drug Labeling and Warnings

SUEZ Gel Formula by is a Otc medication manufactured, distributed, or labeled by SUEZ Water Technologies & Solutions, 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 on 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 104 F (40C)

Inactive ingredients

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

Package Label - Principal Display Panel

80896-010 Gel 10

INGREDIENTS AND APPEARANCE

SUEZ GEL FORMULA 
suez gel formula gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80896-010
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1 mL  in 100 mL
LINALOOL, (+)- (UNII: F4VNO44C09)	0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	1.1 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.01 mL  in 100 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)	0.00035 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: 80896-010-17	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2020
2	NDC: 80896-010-12	1040875 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2020
3	NDC: 80896-010-18	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/23/2020

Labeler - SUEZ Water Technologies & Solutions (009722265)

Registrant - Marquis Extraction Technology LLC (117496233)

Establishment
Name	Address	ID/FEI	Business Operations
Marquis Extraction Technology LLC		117496233	manufacture(80896-010)