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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DawnMist Antibacterial Lotion Soap

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 (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
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: 3/2013
Document Id: da82961d-f51d-426e-a9a2-87339eec7d6e
Set id: d3649061-2880-4142-ab15-ef59213c7d87
Version: 3
Effective Time: 20130321
 
Dukal Corporation