TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ (OCEAN) ANTIBACTERIAL- chloroxylenol liquid 
China Ningbo Shangge Cosmetic Technology Corp.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Purpose

Antibacterial

Active Ingredient

Chloroexylenol, 0.3%

USAGE

For hand washing to decrease bacteria on the skin

Directions

Pump into hands

Lather vigorously for at least 15 seconds

Rinse and dry thoroughly

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away.

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 doctor if irritation and redness develops

WATER, SODIUM LAURETH SULFATE, COCAMIDE MEA, SODIUM C14-16 OLEFIN SULFONATE, SODIUM CHLORIDE, PEG-150 DISTEARATE, FRAGRANCE, CITRIC ACID, GLYCERIN, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, TOCOPHERYL ACETATE, METHYLCHLOROTHIAZOLINONE, METHYLISOTHIAZOLINONE, FD&C YELLOW NO.5, D&C RED NO. 33; FD&C BLUE NO. 1

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TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ (OCEAN)  ANTIBACTERIAL
chloroxylenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-102
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58503-102-01 221 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/06/2017
Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
Name Address ID/FEI Business Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(58503-102)

Revised: 6/2017
Document Id: 5152aed0-99ab-34e3-e054-00144ff8d46c
Set id: 5152aed0-99aa-34e3-e054-00144ff8d46c
Version: 1
Effective Time: 20170606
 
China Ningbo Shangge Cosmetic Technology Corp.