HAND SANITIZER- ethyl alcohol gel 
Yiwu Sloggi Cosmetics Co.,ltd

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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Active Ingredient(s): Ethyl Alcohol 68%

Purpose: Antiseptic

Place enough product on hands to cover all surfaces.

For external use only.

Isopropyl Alcohol

Water

Triethanolamine

Carbomer

Fragrance

Rub hands together until dry.

Keep away from children.

30ml NDC 54225-002-01

30ml label front

30ml label back

100ml NDC 54225-002-02

100ml label front

100ml label back

500ml NDC 54225-002-03

500ml label front

500ml label back

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54225-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 68 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54225-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
2NDC:54225-002-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/04/2020
Labeler - Yiwu Sloggi Cosmetics Co.,ltd (542278522)
Establishment
NameAddressID/FEIBusiness Operations
Yiwu Sloggi Cosmetics Co.,ltd542278522manufacture(54225-002)

Revised: 12/2021
Document Id: d2bfe306-fb8f-14cb-e053-2995a90a9ed3
Set id: a4de2242-a0a8-90ec-e053-2995a90a99b3
Version: 3
Effective Time: 20211209
 
Yiwu Sloggi Cosmetics Co.,ltd