HAND SANITIZER ORIGINAL- seersucker original hand san liquid 
Azar Distilling, 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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seersucker HAND SANITIZER Original

Seersucker Original

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.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria 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

glycerin, hydrogen peroxide, purified water USP, fragrance

Package Label - Principal Display Panel

118 mL NDC: 80750-0002-1 118 mL NDC: 80750-0001-1

HAND SANITIZER ORIGINAL 
seersucker original hand san liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80750-0002(NDC:74793-0001)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
VANILLA (UNII: Q74T35078H) 0.05 mL  in 100 mL
MYRRH OIL (UNII: H74221J5J4) 0.05 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80750-0002-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Azar Distilling, LLC (080288797)
Registrant - Azar Distilling, LLC (080288797)
Establishment
NameAddressID/FEIBusiness Operations
Azar Distilling, LLC080288797label(80750-0002) , repack(80750-0002)

Revised: 11/2020
Document Id: b3fe4280-be9b-89b6-e053-2995a90a38f5
Set id: b3d93dd5-936b-dcc6-e053-2a95a90a38f5
Version: 2
Effective Time: 20201113
 
Azar Distilling, LLC