SANISUDS FOAM ANTIBACTERIAL HAND- triclosan soap 
Palmer Fixture Company

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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Active Ingredient

 Triclosan 0.3% w/w

Purpose

 Skin Antimicrobial

Use

 reduces amount of bacterial on hands

Warnings

For external use only.  Do not use in eyes.
Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.
Not for use on children under six months of age.
For institutional and professional use only.

Directions

  • Wet hands and forearms.
  • Apply a palmful to hands and forearms.
  • Scrub throughly for  at least 15 seconds.
  • Rinse completely and dry.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Propylene Glycol, Sodium Cumenesulfonate, Sodium Chloride, Chloroxylenol DMDM Hydantoin, Fragrance, Yellow 5, Blue 1

Label for 1200 mL Bag (T-3)

SANISUDS FOAM ANTIBACTERIAL HAND 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48417-712
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan3.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sodium Laureth Sulfate (UNII: BPV390UAP0)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Chloride (UNII: 451W47IQ8X)  
Chloroxylenol (UNII: 0F32U78V2Q)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
SODIUM CUMENESULFONATE (UNII: 5798KA13PG)  
Product Characteristics
Colorgreen (apple green, dispensed as white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48417-712-033 in 1 BOX11/11/200909/01/2017
11200 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/11/200909/01/2017
Labeler - Palmer Fixture Company (185454241)

Revised: 7/2017
Document Id: 7a50bbba-1232-47eb-8d88-c8cb0f464258
Set id: dc7b6b76-8a96-478b-b305-1c0279fc16d7
Version: 3
Effective Time: 20170711
 
Palmer Fixture Company