Label: MARQUIS GEL FORMULA gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76585-007-11, 76585-007-12, 76585-007-13, 76585-007-14, view more76585-007-15, 76585-007-16, 76585-007-17, 76585-007-18, 76585-007-20 - Packager: Marquis Extraction Technology LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 July 1, 2020
If you are a consumer or patient please visit this version.
- 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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
MARQUIS GEL FORMULA
marquis gel formula gelProduct 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)