ADVANCED HAND SANITIZER- ethyl alcohol gel 
Dong-A Pharmaceutical Co., Ltd.

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) (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.

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use in or near the eyes, ears, and mouth.

In case of contact, rinse thoroughly with water.

Do not use in the mouth, mucous membrane, or open skin wound as it may cause irritation.

Take precaution when using if allergic to Propylene Glycol.

Stop use and ask a doctor if irritation or rash occurs.

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, Triethanolamine, Hydrogenated Castor Oil, Glycerol, Propylene Glycol, D-Panthenol, Polyacrylic Acid, Lemon, DL-alpha-Tocopherol Acetate

Package Label - Principal Display Panel

500 mL NDC: 77973-800-01 500mL Dong-A Hand Sanitizer

ADVANCED HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77973-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
LEMON (UNII: 24RS0A988O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77973-800-01500 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 - Dong-A Pharmaceutical Co., Ltd. (688733015)
Registrant - Dong-A Pharmaceutical Co., Ltd. (688733015)
Establishment
NameAddressID/FEIBusiness Operations
Dong-A Pharmaceutical Co., Ltd.688733015manufacture(77973-800)

Revised: 6/2020
Document Id: a7aaf3c0-55b9-df78-e053-2a95a90ad06d
Set id: a7ab6699-1b71-2c57-e053-2995a90a13bb
Version: 1
Effective Time: 20200609
 
Dong-A Pharmaceutical Co., Ltd.