HAND SANITIZER- alcohol gel 
THINH PHAT - KOREA SX TM XNK PHARMACEUTICAL COSMETICS COMPANY

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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

for hand washing to decrease bacteria on the skin.

recommended for repeated use.

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

auqa, propylene glycol, fragrance green tea, carbomer, triethanolamine, glycerin

Package Label - Principal Display Panel

70 mL NDC: 78819-101-01

78819-101-01

100 mL NDC: 78819-101-02

78819-101-02

250 mL NDC: 78819-101-03

78819-101-03

500 mL NDC: 78819-101-04

78819-101-04

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78819-101
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
GLYCERIN (UNII: PDC6A3C0OX) 0.02 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.39 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.84 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.2 mL  in 100 mL
GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.3 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78819-101-0170 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78819-101-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78819-101-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78819-101-04500 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 - THINH PHAT - KOREA SX TM XNK PHARMACEUTICAL COSMETICS COMPANY (557260987)
Registrant - THINH PHAT - KOREA SX TM XNK PHARMACEUTICAL COSMETICS COMPANY (557260987)
Establishment
NameAddressID/FEIBusiness Operations
THINH PHAT - KOREA SX TM XNK PHARMACEUTICAL COSMETICS COMPANY557260987manufacture(78819-101)

Revised: 10/2020
Document Id: b1b26da3-bed8-2b9a-e053-2a95a90afa63
Set id: a7a6d24e-359a-d2a0-e053-2a95a90a5475
Version: 3
Effective Time: 20201015
 
THINH PHAT - KOREA SX TM XNK PHARMACEUTICAL COSMETICS COMPANY