HAND SANITIZER- ethyl alcohol gel 
ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD

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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

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

  • in children less than 2 months of age
  • on open skin wounds

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

60mL NDC: 73905-014-08 60mL

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73905-014
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYL ACRYLATE (UNII: 705NM8U35V)  
WATER (UNII: 059QF0KO0R)  
DENATONIUM (UNII: 4IK22DF4OU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73905-014-012 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:73905-014-025 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:73905-014-0310 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:73905-014-0420 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:73905-014-0530 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:73905-014-0645 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:73905-014-0755 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:73905-014-0860 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
9NDC:73905-014-0980 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
10NDC:73905-014-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
11NDC:73905-014-11120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
12NDC:73905-014-12180 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
13NDC:73905-014-13200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
14NDC:73905-014-14236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
15NDC:73905-014-15237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
16NDC:73905-014-16240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
17NDC:73905-014-17250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
18NDC:73905-014-18260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
19NDC:73905-014-19300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
20NDC:73905-014-20350 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
21NDC:73905-014-21400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
22NDC:73905-014-22500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
23NDC:73905-014-23560 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
24NDC:73905-014-24600 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
25NDC:73905-014-25750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
26NDC:73905-014-26900 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
27NDC:73905-014-27980 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
28NDC:73905-014-28985 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
29NDC:73905-014-291000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
30NDC:73905-014-301300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
31NDC:73905-014-311500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
32NDC:73905-014-321800 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
33NDC:73905-014-332000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
34NDC:73905-014-342500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
35NDC:73905-014-353000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
36NDC:73905-014-363800 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
37NDC:73905-014-374000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
38NDC:73905-014-385000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
39NDC:73905-014-3910000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
40NDC:73905-014-4020000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
41NDC:73905-014-4125000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
42NDC:73905-014-4245000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
43NDC:73905-014-4350000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
44NDC:73905-014-44100000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
45NDC:73905-014-45200000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
46NDC:73905-014-46500000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
47NDC:73905-014-471000000 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 Drug505G(a)(3)03/30/202004/23/2024
Labeler - ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD (529558167)
Establishment
NameAddressID/FEIBusiness Operations
ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD529558167manufacture(73905-014)

Revised: 4/2024
Document Id: 165f97a4-8102-f0a4-e063-6394a90a6efd
Set id: a5f98937-d5c0-1396-e053-2995a90a108c
Version: 4
Effective Time: 20240418
 
ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD