FRESH MOUTH - chlorhexidine gluconate spray 
Vedco, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Indications:

To assist in the daily maintenance of a healthy and pleasant smelling mouth in dogs and cats through the removal of food particles and other debris from the teeth and gum line.

Directions:

 Apply Fresh Mouth either as an oral rinse or with a toothbrush.

Oral Rinse: Holding the animal's head steady with one hand, spray a small amount of Fresh Mouth between the teeth and gums on one side of the animal's mouth.  Massage the mouth over the teeth to work Fresh Mouth over the surface of the teeth.  Repeat on the opposite side of the mouth so that the gum surfaces are thoroughly wet on both sides of the mouth.

Tooth Brushing: Place a small amount of Fresh Mouth in a clean dish or cup.  Holding the animal's head steady with one hand, dip the toothbrush into the solution and carefully brush the teeth with a gentle motion.  Re-wet the brush with Fresh Mouth as needed.

Keep Out of Reach of Children

For Animal Use Only

 For Use in Dogs & Cats

Active Ingredient:

 Chlorhexidine 0.1%

Warning:

 Use of Fresh Mouth should not be considered a substitute for sound veterinary dental treatment.  This product should be used under the direction of a veterinarian who can advise on a complete oral health program.  Published literature has reported some staining on teeth surfaces after prolonged use of rinses containing chlorhexidine.  Build up of stain can be prevented by applying the solution with a toothbrush.

Inactive Ingredients:

Surfactants, Ethyl Alcohol 6%, FD&C Red 40, D&C Red 33, Peppermint flavored base.

Principle Display Panel

 Fresh Mouth Label

Fresh Mouth Oral Spray


FRESH MOUTH 
chlorhexidine spray
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50989-916
Route of AdministrationPERIODONTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE1.000 mg  in 1.0 L
Inactive Ingredients
Ingredient NameStrength
Decyl Glucoside50.000 mg  in 1.0 L
ALCOHOL60.000 mg  in 1.0 L
FD&C RED NO. 400.016 mg  in 1.0 L
D&C RED NO. 330.016 mg  in 1.0 L
POLYSORBATE 20125.000 mg  in 1.0 L
PEPPERMINT OIL1.000 mg  in 1.0 L
WATER757.480 mg  in 1.0 L
ANHYDROUS CITRIC ACID1.000 mg  in 1.0 L
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:50989-916-240.240 L in 1 BOTTLE, SPRAYNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/08/2011

Labeler - Vedco, Inc (021634266)
Registrant - Continental Manufacturing Chemist, Inc. (005278007)

Revised: 06/2012 Vedco, Inc