HAND SANITIZER- alcohol liquid 
Yiwu Shining Cosmetics 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 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

Purified Water, Glycerin, Hydrogen Peroxide

Package Label - Principal Display Panel

Hand Sanitizer Bottle Express Employment 60mlHand Sanitizer Bottle-Labels-Lincoln Military Housing-60mlHand Sanitizer NYC YMI Bottle 60mlHand Sanitizer NYPD Bottle 60mlHand Sanitizer Bottle 100mlHand Sanitizer Bottle 200mlHand Sanitizer Microsoft Bottle 500mlHand Sanitizer Sterling Bay Bottle 60mlHand Sanitizer Tube 60ml, NDC: 74862-080-01 Hand Sanitizer Bottle 60ml SewellHand Sanitizer Tube 200mlHand Sanitizer Bottle 60ml ParklandHand Sanitizer Tube 60mlHand Sanitizer Tube 100mlHand Sanitizer Bottle 60ml InspireHand Sanitizer Bottle 5lHand Sanitizer Bottle 500mlHand Sanitizer Bottle 60mlHand Sanitizer Bottle 500ml Inspire

Hand Sanitizer Tube 100ml, NDC: 74862-080-02

Hand Sanitizer Tube 200ml, NDC: 74862-080-03

Hand Sanitizer Bottle 60ml, NDC: 74862-080-04

Hand Sanitizer Bottle 500ml, NDC: 74862-080-05

Hand Sanitizer Bottle 5l, NDC: 74862-080-06

Hand Sanitizer Bottle 60ml Inspire, NDC: 74862-080-07

Hand Sanitizer Bottle 500ml Inspire, NDC: 74862-080-08

Hand Sanitizer Bottle 60ml Parkland, NDC: 74862-080-09

Hand Sanitizer Bottle 60ml Sewell, NDC: 74862-080-10

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74862-080
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) 18.425 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74862-080-0160 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2020
2NDC:74862-080-02100 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2020
3NDC:74862-080-03200 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2020
4NDC:74862-080-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
5NDC:74862-080-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
6NDC:74862-080-065000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
7NDC:74862-080-0760 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
8NDC:74862-080-08500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
9NDC:74862-080-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
10NDC:74862-080-1060 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
11NDC:74862-080-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
12NDC:74862-080-12100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
13NDC:74862-080-13200 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
14NDC:74862-080-14500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
15NDC:74862-080-1560 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
16NDC:74862-080-1660 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
17NDC:74862-080-1760 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
18NDC:74862-080-1860 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2020
Labeler - Yiwu Shining Cosmetics Co ltd (543002719)

Revised: 6/2020
Document Id: a86465e3-404f-23fb-e053-2995a90ab96f
Set id: a297b2b8-5d4b-f5b3-e053-2a95a90a6598
Version: 6
Effective Time: 20200618
 
Yiwu Shining Cosmetics Co ltd