DAWNMIST ANTIBACTERIAL- triclosan gel
Dukal 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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Active Ingredient

Triclosan .3%

Purpose

Antibacterial Agent

Use

For hand washing to decrease bacteria on skin.

Warnings

For external use only ■ Do not use in the
eyes ■ In rare instances of irritation, discontinue use ■ If
condition persists for more than 72 hours consult a physician
■ If swallowed contact a physician or poison control center.

Keep out of reach of children

Directions

To decrease bacteria on skin apply sufficient
amount to cover hands. Add water, lather and rinse.

Inactive Ingredients

Water, Sodium Laureth Sulfate,
Cocamine Oxide, Sodium Chloride, Cocamidopropyl
Betaine, Propylene Glycol, DMDM Hydantoin, Fra grance,
FDC Blue #1

Package Label

DawnMist

Kills Germs
and Bacteria
on Contact

Melon Scent

Antibacterial
Lotion Soap

8 FL. OZ. (236ml)

Manufactured for:
DUKAL CORPORATION
Ronkonkoma, NY 11779
(631) 656-3800
www.dukal.com

label

DAWNMIST ANTIBACTERIAL
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65517-1001
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (TRICLOSAN)	TRICLOSAN	3 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
SODIUM LAURETH-3 SULFATE
COCAMINE OXIDE
SODIUM CHLORIDE
COCAMIDOPROPYL BETAINE
PROPYLENE GLYCOL
DMDM HYDANTOIN
FD&C BLUE NO. 1

Packaging
#	Item Code	Package Description
1	NDC:65517-1001-1	236 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/10/2013

Labeler - Dukal Corporation (791014871)

Revised: 01/2013

Document Id: 6d8387f0-6dae-4b75-9caa-f94f42318d8c

Set id: d3649061-2880-4142-ab15-ef59213c7d87

Version: 1

Effective Time: 20130110

Dukal Corporation