SUPEFIN Hypochlorous acid Disinfectant

Hypochlorous acid Disinfectant by

Drug Labeling and Warnings

Hypochlorous acid Disinfectant by is a Otc medication manufactured, distributed, or labeled by JUYCAN (Beijing) Pharmaceutical Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYPOCHLOROUS ACID DISINFECTANT- hypochlorous acid liquid 
JUYCAN (Beijing) Pharmaceutical Technology 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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SUPEFIN Hypochlorous acid Disinfectant

Active Ingredient(s)

Hypochlorous Acid >=100 mg/L

Purpose

Antimicrobial

Use

To prevent and treat an infection of the skin.

Warnings

For external use only.

Do not use

If sensitive to chlorine compounds

Do not mix with other chemicals

Use sterilization tank only with plastic or SUS-316 or higher material for complete sterilization

Please do not drink

Use within 12 months from the date of manufacture for complete sterilization.

Stop use and ask a doctor if redness, irritation or swelling or pain persists or increases.

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 redness, irritation or swelling or pain persists or increases

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use as liquid Sterilization by immersing completely for about 3 to 5 minutes. For instruments that are difficult to deposit, spray and sterilize for about 3 minutes before wiping off.

Other information

Use this product only below 65˚C

Do not deposit for more than 30 minutes to prevent corrosion and damage to equipment made of ferrous metal.

Inactive ingredients

Water, Nacl

Package Label - Principal Display Panel

100 mL NDC: 90053-001-02

5L NDC: 90053-001-07

HYPOCHLOROUS ACID DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90053-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	10 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90053-001-01	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
2	NDC: 90053-001-02	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
3	NDC: 90053-001-03	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
4	NDC: 90053-001-04	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
5	NDC: 90053-001-05	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
6	NDC: 90053-001-06	2000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
7	NDC: 90053-001-07	5000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
8	NDC: 90053-001-08	10000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
9	NDC: 90053-001-09	20000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020
10	NDC: 90053-001-10	25000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/10/2020	11/22/2021

Labeler - JUYCAN (Beijing) Pharmaceutical Technology Co., Ltd. (554539980)

Registrant - JUYCAN (Beijing) Pharmaceutical Technology Co., Ltd. (554539980)

Establishment
Name	Address	ID/FEI	Business Operations
JUYCAN (Beijing) Pharmaceutical Technology Co., Ltd.		554539980	manufacture(90053-001)

Revised: 11/2021

Document Id: d1776459-0b07-e894-e053-2995a90af8a4

34390-5

Set id: aef29807-89f1-745b-e053-2995a90a617f

Version: 3

Effective Time: 20211123

 

JUYCAN (Beij