SEVEN THREE HAND SANITIZER- alcohol antiseptic 70% gel

Seven Three Hand Sanitizer by

Drug Labeling and Warnings

Seven Three Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Seven Three Distilling Company, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

Active Ingredient(s)

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

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

Stop use and ask a doctor if skin irritation develops.

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.125 mL  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)	0.002 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	5.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75219-7300-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

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	Business Operations
Seven Three Distilling Company, LLC		087822184	manufacture(75219-7300)