HAND SANITIZER- alcohol gel 
TRANG LY PHARMA TRADE COMPANY LIMITED

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 80% v/v. Purpose: Antiseptic

Purpose

Antimicrobial

Use

Dry Hand Sanitizer helps prevent the development of bacteria on the skin.

It moisturizes and softens the hand skin with the sweet fragrance.

Warnings

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

Do not use


Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.


For children: need to be supervised by adults when using it.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Keep our of reach of children

Package Label - Principal Display Panel

100 mL NDC: 90098-100-01

90098-100-01

250 mL NDC: 90098-100-02

90098-100-02

500 mL NDC: 90098-100-03

90098-100-03

1000 mL NDC: 90098-100-04

90098-100-04

2000 mL NDC: 90098-100-05

90098-100-05

10000 mL NDC: 90098-100-06

90098-100-06

20000 mL NDC: 90098-100-07

90098-100-07

59 mL NDC: 90098-100-08

90098-100-08

1 Gallon NDC: 90098-100-09

90098-100-09

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90098-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 22 mL  in 100 mL
MINT (UNII: FV98Z8GITP) 6 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90098-100-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:90098-100-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:90098-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:90098-100-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:90098-100-052000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:90098-100-0610000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:90098-100-0720000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:90098-100-0859 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
9NDC:90098-100-0920000 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 - TRANG LY PHARMA TRADE COMPANY LIMITED (555252970)
Registrant - TRANG LY PHARMA TRADE COMPANY LIMITED (555252970)
Establishment
NameAddressID/FEIBusiness Operations
TRANG LY PHARMA TRADE COMPANY LIMITED555252970manufacture(90098-100)

Revised: 10/2020
Document Id: b1b26869-06e7-f77c-e053-2995a90a3b8f
Set id: ac41d70d-0046-783e-e053-2995a90a9a58
Version: 4
Effective Time: 20201015
 
TRANG LY PHARMA TRADE COMPANY LIMITED