ANTIBACTERIAL HANDSOAP WITH MOISTURIZER- 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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47993-277

Active ingredients

Chloroxylenol 0.3%

Antibacterial

Uses:

For hanbwashing to decrease bacteria on the skin.

Warnings:

For external use only. 

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctorif irritation or redness develops.

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

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation or redness develops.

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

Directions:

Other information:

Inactive Ingredients:

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

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ANTIBACTERIAL HANDSOAP WITH MOISTURIZER 
chloroxylenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-277
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)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-277-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/2020
2NDC:47993-277-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/2020
3NDC:47993-277-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/17/2020
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Revised: 11/2020
Document Id: b3566df4-d219-5f7d-e053-2a95a90adae6
Set id: 6cee1f45-16c5-4711-ad7a-34315171c759
Version: 2
Effective Time: 20201105
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD