HAND SANITIZER- alcohol gel 
ningbo fareast industry co.,ltd
Reference Label Set Id: a68674ba-455a-4d63-e053-2a95a90aed00

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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alcohol 75% v/v purpose :antiseptic

alcohol 70% v/v purpose :antiseptic

alcohol 60% v/v purpose :antiseptic

to help reduce bacteria that potentially can cause disease.for use when soap and water are not available

for external use only,flammable,keep away from heat or flame

. 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 thorough 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 irriation 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 posion control center right away

place enough product on hands to cover all surface,rub hands together until dry
supervise children under 6 years when using this product to avoid swallowing

package label principal display panel

30ml-70percent alcohol30ml-75percent alcohol30ml-60percent alcohol60ml-75percent alcohol60ml-70percent alcohol60ml-60percent alcohol100ml-75percent alcohol100ml percent alcohol100ml - 60percent alcohol237ml - 75percent alcohol237- 70percent alcohol237ml- 60percent alcohol500ml -75 percent alcohol500ml-70 percent alcohol500ml-60percent alcohol1000ml - 75 percent alcohol1000ml - 70percent alcohol 1000ml- 60 percent alcohol 75% alcohol concent

1000ml NDC: 78623-375-01

500ml NDC: 78623-375-02

237ml NDC: 78623-375-03

100ml NDC: 78623-375-04

60ml NDC: 78623-375-05

30ml NDC: 78623-375-06

70% alcohol concent

1000ml NDC: 78623-370-01

500ml NDC: 78623-370-02

237ml NDC: 78623-370-03

100ml NDC: 78623-370-04

60ml NDC: 78623-370-05

30ml NDC: 78623-370-06

60% alcohol concent

1000ml NDC: 78623-360-01

500ml NDC: 78623-360-02

237ml NDC: 78623-360-03

100ml NDC: 78623-360-04

60ml NDC: 78623-360-05

30ml NDC: 78623-360-06

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78623-370
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78623-370-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
2NDC:78623-370-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
3NDC:78623-370-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
4NDC:78623-370-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
5NDC:78623-370-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
6NDC:78623-370-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/31/2020
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78623-375
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78623-375-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
2NDC:78623-375-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
3NDC:78623-375-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
4NDC:78623-375-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
5NDC:78623-375-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
6NDC:78623-375-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/04/2021
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78623-360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78623-360-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
2NDC:78623-360-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
3NDC:78623-360-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
4NDC:78623-360-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
5NDC:78623-360-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
6NDC:78623-360-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/04/2021
Labeler - ningbo fareast industry co.,ltd (554535808)

Revised: 1/2021
Document Id: b7c0190b-1399-b210-e053-2a95a90ab08d
Set id: a79f7aca-9403-a319-e053-2a95a90a9d29
Version: 3
Effective Time: 20210104
 
ningbo fareast industry co.,ltd