SEVEN THREE HAND SANITIZER- alcohol antiseptic 70% 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.

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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) (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

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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

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

Other information

Inactive ingredients

water, glycerin, carbopol, lemongrass oil

Purpose

Antiseptic, Hand Sanitizer

Package Label - Principal Display Panel

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

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SEVEN THREE HAND SANITIZER 
alcohol antiseptic 70% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75219-7300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.125 mL  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75219-7300-13785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Seven Three Distilling Company, LLC (087822184)
Establishment
NameAddressID/FEIBusiness Operations
Seven Three Distilling Company, LLC087822184manufacture(75219-7300)

Revised: 2/2021
Document Id: baee9733-a790-6891-e053-2a95a90ab80c
Set id: a342115c-36ce-0e7e-e053-2995a90a35c5
Version: 15
Effective Time: 20210209
 
Seven Three Distilling Company, LLC