Seven Three Hand Sanitizer: Package Insert and Label Information

SEVEN THREE HAND SANITIZER- hydrogen peroxide and alcohol gel
Seven Three Distilling Company, 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) (70%, 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.
5. Methacrylic Acid — Ethyl Acrylate Copolymer (5.5% v/v)

The firm does add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Ethanol 70%. Purpose: Antiseptic

Hydrogen Peroxide <1%. Purpose: Antiseptic

Use

• For handwashing to decrease bacteria on the skin
• recommended for repeated use

Warnings

For external use only — hands.

Flammable. Keep away from heat or flame.

When usting this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

• for children under 6, use only under adult supervision
• not recommended for infants
• avoid contact with broken skin

When using this product keep out of eyes. In case of contact with eyes, flush thoroghly with water.

Avoid contact with broken skin.

Do not ingest or inhale.

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. If swallowed, get medical help or help or contact a Poison Control Center right away.

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wet hands thoroughly with product and allow to dry without wiping.
• For childres under 6, use only under adult supervision
• Not recommended for infants

Other information

• Do not store above 105°F
• May discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

water, glycerin, carbopol, lemongrass oil

Purpose

Antiseptic, Hand Sanitizer

Package Label — Principal Display Panel

128 FL OZ (3785ML) 75219-7300-1

73_gel

SEVEN THREE HAND SANITIZER alcohol antiseptic 70% gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75219-7300 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE 0.125 mL in 100 mL ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WEST INDIAN LEMONGRASS OIL 0.002 mL in 100 mL METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S) 5.5 mL in 100 mL GLYCERIN 1.45 mL in 100 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:75219-7300-1 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 03/30/2020

Labeler — Seven Three Distilling Company, LLC (087822184)

Establishment
Name	Address	ID/FEI	Operations
Seven Three Distilling Company, LLC		087822184	manufacture (75219-7300)

Revised: 02/2021 Seven Three Distilling Company, LLC