ANTIMICROBIALSOAP- 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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47993-325

Active ingredients

Chloroxylenol 0.75% w/w

Antiseptic

Uses:

Warnings:

For external use only.

When using this product

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions:

Other information:

Inactive ingredients:

Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No.8, FD&C Blue No.1, FD&C Yellow No.5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Water.

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ANTIMICROBIALSOAP 
chloroxylenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-325
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
COCO-BETAINE (UNII: 03DH2IZ3FY)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
D&C GREEN NO. 8 (UNII: I2W85YOX9L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
OLEIC ACID (UNII: 2UMI9U37CP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
EDETATE SODIUM (UNII: MP1J8420LU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-325-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2021
2NDC:47993-325-02532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2021
3NDC:47993-325-03800 mL in 1 BAG; Type 0: Not a Combination Product06/15/2021
4NDC:47993-325-043800 mL in 1 BOTTLE; 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: c4f12df0-da51-d05b-e053-2a95a90a1a8b
Set id: 69723b40-606f-446f-970f-528e7b85c9ae
Version: 1
Effective Time: 20210617
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD