HAND SANITIZER- alcohol liquid 
Guangzhou Jieyi Daily Chemical Products 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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Hand Sanitizer

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) (75%, 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. Aristoflex AVC
  3. 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 75% v/v

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

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

Deionized Water
Aristoflex AVC

Package Label - Principal Display Panel

601003005001000

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76844-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76844-101-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:76844-101-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:76844-101-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:76844-101-04300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:76844-101-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:76844-101-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:76844-101-0715 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:76844-101-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
9NDC:76844-101-093000 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 - Guangzhou Jieyi Daily Chemical Products Co., Ltd. (527941938)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Jieyi Daily Chemical Products Co., Ltd.527941938manufacture(76844-101)

Revised: 5/2020
Document Id: a4e584c1-d9c6-cdf1-e053-2995a90a06dc
Set id: a43c324c-cc1c-025d-e053-2995a90ac9c3
Version: 2
Effective Time: 20200505
 
Guangzhou Jieyi Daily Chemical Products Co., Ltd.