DISINFECTANT- hypochlorous acid liquid 
Shera Heman Zhejiang Biotechnologies 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

HYPOCHLOROUS ACID 0.01% v/v

Water

HYPOCHLOROUS ACID 0.01% v/v

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

Sterilize by spraying on objects or skin surface

For external use only.

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

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.

Spray on the surface of objects or human skin

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

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

water

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

001002003004005006007

DISINFECTANT 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74457-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2020
DISINFECTANT 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74457-007-0125 L in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2020
DISINFECTANT 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74457-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2020
DISINFECTANT 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74457-003-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2020
DISINFECTANT 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74457-004-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2020
DISINFECTANT 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74457-005-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2020
DISINFECTANT 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74457-006-014 L in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2020
Labeler - Shera Heman Zhejiang Biotechnologies Co.,Ltd. (554528847)
Establishment
NameAddressID/FEIBusiness Operations
Shera Heman Zhejiang Biotechnologies Co.,Ltd.554528847manufacture(74457-001, 74457-002, 74457-003, 74457-004, 74457-005, 74457-006, 74457-007)

Revised: 4/2020
Document Id: a2b1dd35-75e0-235b-e053-2a95a90a074e
Set id: a2b1dd35-75df-235b-e053-2a95a90a074e
Version: 1
Effective Time: 20200407
 
Shera Heman Zhejiang Biotechnologies Co.,Ltd.