FOAMING ANTIBACTERIAL  PEAR- triclosan soap 
Topco Associates LLC

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.

----------

Drug Facts Box - Back Label

Active Ingredient

Triclosan 0.46%

Purpose

Antibacterial


Warnings

For external use only.

Stop using this product and ask doctor if

Irritation or redness develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Uses

For washing to decrease bacteria on the skin.

Directions

Pump onto dry hands, Work into a lather vigorously and rinse thoroughly.

Inactive Ingredients

Water (Aqua), Sodium Xylene Sulfonate, Dipropylene Glycol, Glycerin, Sodium PCA, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Polyquaternium-10, Fragrance (Parfum), Disodium Phosphate, Cetyl Alcohol, Aloe Barbadensis Leaf Juice, Citric Acid, Methylparaben, Propylparaben, Green 3 (CI 42053), Yellow 10 (CI 47005)

PACKAGE FRONT AND BACK LABELS

7.5OZ Front and Back Labels: tc8.jpg7.5OZ FRONT AND BACK LABELS

FOAMING ANTIBACTERIAL   PEAR
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-163
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.4600 mL  in 100.0000 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-163-08222 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/26/2010
Labeler - Topco Associates LLC (006935977)

Revised: 7/2010
Document Id: a04a5af5-3839-4ad3-b9d9-71c1a9ca407d
Set id: f39b2c7c-4915-444a-b4ac-09e097791f40
Version: 1
Effective Time: 20100726
 
Topco Associates LLC