SUEZ GEL FORMULA- suez gel formula gel 
SUEZ Water Technologies & Solutions

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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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

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 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.

Directions

Other information

Inactive ingredients

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

Package Label - Principal Display Panel

Gel 010Gel 010Gel 01080896-010 Gel 10

SUEZ GEL FORMULA 
suez gel formula gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80896-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80896-010-173785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
2NDC:80896-010-121040875 mL in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
3NDC:80896-010-18355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/23/2020
Labeler - SUEZ Water Technologies & Solutions (009722265)
Registrant - Marquis Extraction Technology LLC (117496233)
Establishment
NameAddressID/FEIBusiness Operations
Marquis Extraction Technology LLC117496233manufacture(80896-010)

Revised: 10/2020
Document Id: b25beeda-aca2-b598-e053-2a95a90a5716
Set id: b25bf001-a9d1-3630-e053-2a95a90af9fd
Version: 1
Effective Time: 20201023
 
SUEZ Water Technologies & Solutions