Label: DISINFECTANT- hypochlorous acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 74524-101-01, 74524-101-02, 74524-101-03, 74524-101-04 - Packager: Shanghai Qunli Enterprise (Group) Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated April 8, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
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)
- 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.
- HYPOCHLOROUS ACID
- 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)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
DISINFECTANT
hypochlorous acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74524-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID 1 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) 50 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74524-101-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:74524-101-02 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 3 NDC:74524-101-03 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 4 NDC:74524-101-04 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/30/2020 Labeler - Shanghai Qunli Enterprise (Group) Co., Ltd. (553457671) Establishment Name Address ID/FEI Business Operations Shanghai Qunli Enterprise (Group) Co., Ltd. 553457671 manufacture(74524-101)