DISINFECTANT- hypochlorous acid liquid 
Shanghai Qunli Enterprise (Group) Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Disinfectant

The disinfectant is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation)

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (50%, 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. HYPOCHLOROUS ACID
  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)

HYPOCHLOROUS ACID 1mg/100mL

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

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

ALCOHOL
WATER

Package Label - Principal Display Panel

15 mL NDC: 74524-101-01

30 mL NDC: 74524-101-02

60 mL NDC: 74524-101-03

100 mL NDC: 74524-101-04

label

DISINFECTANT 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74524-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M) 50 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74524-101-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74524-101-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:74524-101-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:74524-101-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/30/2020
Labeler - Shanghai Qunli Enterprise (Group) Co., Ltd. (553457671)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Qunli Enterprise (Group) Co., Ltd.553457671manufacture(74524-101)

Revised: 4/2020
Document Id: a2cba50b-d5fb-9cd5-e053-2a95a90a58f0
Set id: a2cba50b-d5fa-9cd5-e053-2a95a90a58f0
Version: 1
Effective Time: 20200408
 
Shanghai Qunli Enterprise (Group) Co., Ltd.