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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54225-012

Active Ingredient(s)

Active Ingredient(s): Ethyl Alcohol 68%

Purpose

Purpose: Antiseptic

Use

Rub hands together until dry.

Warnings

For external use only.

Do not use

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.

Directions

Other information

Inactive ingredients

Isopropyl Alcohol

Water

Triethanolamine

Carbomer

Fragrance

Package Label - Principal Display Panel

30 mL NDC: 54225-012-01

30ml label130ml label2

100 mL NDC: 54225-012-02

100ml label1100ml label2

500 mL NDC: 54225-012-03

500ml label1500ml label2

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54225-012
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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54225-012-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
2NDC:54225-012-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
3NDC:54225-012-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
Image of Product
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)
Registrant - YIWU SLOGGI COSMETICS COLTD (542278522)
Establishment
NameAddressID/FEIBusiness Operations
YIWU SLOGGI COSMETICS CO.,LTD542278522manufacture(54225-012)

Revised: 6/2020
Document Id: a73a205a-4504-5583-e053-2a95a90a26ea
Set id: a73a3365-ea15-d17e-e053-2995a90a8bac
Version: 1
Effective Time: 20200603
 
Yiwu Sloggi Cosmetics Co.,ltd