TRICLOSAN- antibacterial liquid soap refill soap 
Brands International

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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Antibacterial Liquid Soap Refill

Drug Facts

Active Ingredients

Triclosan 0.115%

Purpose

Antibacterial

Uses

for handwashing or decrease bacteria to the skin

For external use only

Stop use and ask a doctor if

irritation or redness develops

When using this product

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Inactive Ingredients

Water, Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Citric Acid, Fragrance, EDTA, Yellow #5, Red# 33

Package Label

​Spa Soap

Antibacterial

Liquid Soap

Refill Antibacterial Liquid Soap

TRICLOSAN 
antibacterial liquid soap refill soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETIC ACID (UNII: 9G34HU7RV0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-119-32947 mL in 1 BOTTLE; Type 0: Not a Combination Product02/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/03/2016
Labeler - Brands International (243748238)
Registrant - Sante Manufacturing Inc (252365486)
Establishment
NameAddressID/FEIBusiness Operations
Brands International243748238manufacture(50157-119)

Revised: 5/2016
Document Id: 34100d44-e308-6fc0-e054-00144ff8d46c
Set id: 2ae1fa17-272e-2cca-e054-00144ff8d46c
Version: 3
Effective Time: 20160530
 
Brands International