SIMPLE PLEASURES ANTIBACTERIAL FOAMING HAND- triclosan soap 
Tri-Coastal Design Company Inc.

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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Drug Facts

Active Ingredient

Triclosan 0.3%

Purpose

Antiseptic

Uses

Warnings

If taken internally will produce serious gastric disturbances

When using this product

Stop use and ask a doctor if

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

Other information

Inactive Ingredients

Benzophenone-4, Citric Acid, Cocamidopropyl Betaine, Cocamide DEA, Disodium EDTA, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Sodium Laureth Sulfate, Water (Aqua)

Package Label

image description

SIMPLE PLEASURES  ANTIBACTERIAL FOAMING HAND
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-172
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZOPHENONE (UNII: 701M4TTV9O)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49852-172-08240 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/21/2012
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture(49852-172)

Revised: 10/2012
Document Id: 9c04c602-a1ca-4039-a187-c7914add7948
Set id: 4760b9f8-43ce-4bd8-b2f9-30fa36d18f2a
Version: 1
Effective Time: 20121004
 
Tri-Coastal Design Company Inc.