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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47993-326

Active ingredients

Chloroxylenol 0.3% 

Antibacterial

Use for handwashing to decrease bacteria on the skin.

Warnings:

For external use only: hands only.

When using this product avoid contact with eyes. If contact occurs, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.

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

Directions:

Apply onto wet hands, lather for at least 30 seconds and rinse thoroughly.

Other information:

Avoid freezing and excessive heat above 40℃ (104℉).

Inactive ingredients:

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, GLYCERIN, COCAMIDE METHYL MEA, SODIUM CHLORIDE, PARFUM, CHLOROXYLENOL, CITRIC ACID, DISODIUM EDTA, METHYLCHLOROISOTHIAZOLINONE AND METHYLISOTHIAZOLINONE, DYE

image of hand sanitizer 473ml-3image of hand sanitizer 473ml-2image of hand sanitizer 1000ml-1image of hand sanitizer 1000ml-2image of hand sanitizer 1000ml-3image of hand sanitizer 473ml-1

HANDSOAP 
chloroxylenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-326
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-326-01473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2021
2NDC:47993-326-021000 mL in 1 BAG; Type 0: Not a Combination Product06/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2021
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Revised: 6/2021
Document Id: c4f1422b-b877-5f56-e053-2a95a90ab2ce
Set id: c4fbbda4-69cf-48e9-96f9-0aeb9ef51404
Version: 1
Effective Time: 20210617
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD