GEL HAND SANITIZER- gel hand sanitizer gel 
Marquis Extraction Technology LLC

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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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 0% 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

acrylates copolymer, alpha-tocopherol acetate, detaonium benzoate, glycerin, isopropyl myristate, Propylene glycol, Tert-butyl alcohol, triisopropylamine

Package Label - Principal Display Panel

NDC 76585-003-20

59 mL NDC: 76585-003-20

GEL HAND SANITIZER 
gel hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76585-003
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) 0.5 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 4 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
TRIISOPROPYLAMINE (UNII: Y67CF9Z56L) 0.7 mL  in 100 mL
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.005 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76585-003-2059 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
2NDC:76585-003-1618927 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
3NDC:76585-003-18355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
4NDC:76585-003-121040875 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
5NDC:76585-003-1512113 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
6NDC:76585-003-14946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
7NDC:76585-003-13236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
8NDC:76585-003-11473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
9NDC:76585-003-173785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/04/2020
Labeler - Marquis Extraction Technology LLC (117496233)
Establishment
NameAddressID/FEIBusiness Operations
Marquis Extraction Technology LLC117496233manufacture(76585-003)

Revised: 6/2020
Document Id: a7fcbcc2-5313-4d41-e053-2a95a90a38e2
Set id: a7a7e50d-ee52-3e44-e053-2a95a90a6803
Version: 2
Effective Time: 20200613
 
Marquis Extraction Technology LLC