HANDSOAP- chloroxylenol gel 
NINGBO JIANGBEI OCEAN STAR TRADING 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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47993-324

Active ingredients

Chloroxylenol 0.3%

Antibacterial

Uses:

Warnings:

When using this product

Stop use and ask a doctor if

Keep out of reach of children

Directions:

Inactive Ingredients:

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, GLYCERIN, COCAMIDE METHYL MEA, SODIUM CHLORIDE, FRAGRANCE, DMDM HYDANTION, CITRIC ACID, DISODIUM EDTA, DYE.

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HANDSOAP 
chloroxylenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-324
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
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-324-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/07/2021
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Revised: 6/2021
Document Id: c42df83a-be30-c4ff-e053-2a95a90aa81d
Set id: 060a009e-0027-43ef-8584-4899272bcd54
Version: 1
Effective Time: 20210607
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD