SEPTISOL NPD WITH TRICLOSAN  ANTISEPTIC- triclosan liquid 
STERIS Corporation

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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SEPTISOL® NPD WITH TRICLOSAN
Antiseptic Handwash

Drug Facts

Active ingredient

0.25% Triclosan

Purpose

Antiseptic Handwash

Use

decreases the level of transient microorganisms on the skin

Warnings

For external use only

Stop use and ask a doctor if irritation and redness develop and persist for more than 5 days.

When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Wet skin and spread a small amount of Septisol NPD with Triclosan on the hands. Wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts.

Inactive ingredients

Water, sodium C14-C16 olefin sulfonate, sorbitol, hydroxyethylecellulose, citric acid

Questions or comments?

USA 1-800-548-4873

PRINCIPAL DISPLAY PANEL - 3.78 Liter Bottle Label

NDC 0519-1357-08

SEPTISOL® NPD WITH TRICLOSAN

Antiseptic Handwash

Net Contents: 3.78 Liters (1 Gal.)
1357-08

PRINCIPAL DISPLAY PANEL - 3.78 Liter Bottle Label
SEPTISOL NPD WITH TRICLOSAN   ANTISEPTIC
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0519-1357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
sodium C14-16 olefin sulfonate (UNII: O9W3D3YF5U)  
sorbitol (UNII: 506T60A25R)  
citric acid monohydrate (UNII: 2968PHW8QP)  
Product Characteristics
ColorWHITE (Off-White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0519-1357-083078 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/201110/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E03/25/201110/15/2018
Labeler - STERIS Corporation (139424188)
Establishment
NameAddressID/FEIBusiness Operations
STERIS Corporation139424188MANUFACTURE(0519-1357)

Revised: 10/2018
Document Id: e807ace1-85b2-425b-9715-45a6c02e5146
Set id: 550422ac-922c-4a56-8d1f-ae8cb4653862
Version: 2
Effective Time: 20181022
 
STERIS Corporation