Gel Hand Sanitizer: Package Insert and Label Information

GEL HAND SANITIZER- alcohol 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.

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.

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

• in children less than 2 months of age
• on open skin wounds
• in eyes

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

• 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 40C (104F)

Inactive ingredients

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

Package Label — Principal Display Panel

59 mL NDC: 76585-003-20

GEL HAND SANITIZER gel hand sanitizer gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76585-003 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL 0.5 mL in 100 mL METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S) 4 mL in 100 mL ISOPROPYL MYRISTATE 0.1 mL in 100 mL GLYCERIN 1 mL in 100 mL WATER TRIISOPROPYLAMINE 0.7 mL in 100 mL ALPHA-TOCOPHEROL 0.005 mL in 100 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76585-003-20 59 mL in 1 BOTTLE None 2 NDC:76585-003-16 18927 mL in 1 BOTTLE None 3 NDC:76585-003-18 355 mL in 1 BOTTLE None 4 NDC:76585-003-12 1040875 mL in 1 BOTTLE None 5 NDC:76585-003-15 12113 mL in 1 BOTTLE None 6 NDC:76585-003-14 946 mL in 1 BOTTLE None 7 NDC:76585-003-13 236 mL in 1 BOTTLE None 8 NDC:76585-003-11 473 mL in 1 BOTTLE None 9 NDC:76585-003-17 3785 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/04/2020

Labeler — Marquis Extraction Technology LLC (117496233)

Establishment
Name	Address	ID/FEI	Operations
Marquis Extraction Technology LLC		117496233	manufacture (76585-003)

Revised: 06/2020 Marquis Extraction Technology LLC