Label: SUEZ GEL FORMULA gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80896-010-12, 80896-010-17, 80896-010-18 - Packager: SUEZ Water Technologies & Solutions
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated October 23, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SUEZ GEL FORMULA
suez gel formula gelProduct 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)