Your browser does not support JavaScript! DAWNMIST ANTIBACTERIAL (TRICLOSAN) GEL [DUKAL CORPORATION]
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DAWNMIST ANTIBACTERIAL (triclosan) gel
[Dukal Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65517-1001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH-3 SULFATE 
COCAMINE OXIDE 
SODIUM CHLORIDE 
COCAMIDOPROPYL BETAINE 
PROPYLENE GLYCOL 
DMDM HYDANTOIN 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-1001-1236 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/10/2013
Labeler - Dukal Corporation (791014871)

Revised: 3/2013
 
Dukal Corporation

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