ANTIBACTERIAL HAND SANITIZER- chloroxylenol solution 
ZHONGSHAN DIOS TRADING COMMERCIAL 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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Drug Fact

Active Ingredient(s)

CHLOROXYLENOL: 0.3%. Purpose: Antiseptic

Purpose

Antiseptic

Use

Use: Used for antibacterial cleaning of hand skin

Warnings

Warning: For external use only. Discontinue use if skin irritation occurs. If accidentally into the eyes, please rinse thoroughly with clean water.

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

Directions: This product is shuitable for hand cleaning. Light pressure pump head, apply proper amount of hand sanitizer into palms, rub well and rinse with water

Inactive ingredients

Inactive Ingredients: Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Carbomer, Sodium Hydroxide, DMDM Hydantoin, Aroma

Storage: Store in cool dry place away from light at room temperature

Package Label - Principal Display Panel

image description

ANTIBACTERIAL HAND SANITIZER 
chloroxylenol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74532-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOMER 934 (UNII: Z135WT9208)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74532-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/04/2020
Labeler - ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD. (542141447)
Establishment
NameAddressID/FEIBusiness Operations
ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD.542141447manufacture(74532-001)

Revised: 4/2020
Document Id: a2a459ae-4946-0a57-e053-2995a90a4418
Set id: f656b969-ba1e-44d0-9ad3-f1f55e8de9c4
Version: 1
Effective Time: 20200406
 
ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD.