DISINFECTANT- hypochlorous acid liquid

Disinfectant by

Drug Labeling and Warnings

Disinfectant by is a Otc medication manufactured, distributed, or labeled by Shera Heman Zhejiang Biotechnologies Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

HYPOCHLOROUS ACID 0.01% v/v

Water

ACTIVE INGREDIENT

HYPOCHLOROUS ACID 0.01% v/v

PURPOSE

Products used to kill bacteria and viruses, prevent disease, and suppress spread

INDICATIONS & USAGE

Sterilize by spraying on objects or skin surface

WARNINGS

For external use only.

DO NOT USE

in children less than 2 months of age
on open skin wounds

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

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

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

DOSAGE & ADMINISTRATION

Spray on the surface of objects or human skin

Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

water

PRINCIPAL DISPLAY PANEL

50mL NDC: 74457-001-01

100mL NDC: 74457-002-01

300mL NDC: 74457-003-01

500mL NDC: 74457-004-01

1000mL NDC: 74457-005-01

4L NDC: 74457-006-01

25L NDC: 74457-007-01

INGREDIENTS AND APPEARANCE

DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74457-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74457-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2020

DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74457-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.1 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74457-007-01	25 L in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2020

DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74457-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74457-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2020

DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74457-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74457-003-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2020

DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74457-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74457-004-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2020

DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74457-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74457-005-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2020

DISINFECTANT 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74457-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.1 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74457-006-01	4 L in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2020

Labeler - Shera Heman Zhejiang Biotechnologies Co.,Ltd. (554528847)

Establishment
Name	Address	ID/FEI	Business Operations
Shera Heman Zhejiang Biotechnologies Co.,Ltd.		554528847	manufacture(74457-001, 74457-002, 74457-003, 74457-004, 74457-005, 74457-006, 74457-007)