Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse

Dosage form: liquid
Ingredients: SODIUM FLUORIDE 0.05mL in 100mL
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-300

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.

Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse

Active ingredient                                                                    
Sodium fluoride 0.05% (0.02% w/v fluoride ion).........................

Purpose: Anticavity Rinse

Uses - Aids in the prevention of dental cavities

Keep out of reach of children under 6 years of age.

Warnings

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

- Adults and children 6 years of age and older. Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. - Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). - Supervise children as necessary untill capable of using without supervision. - Children under 6 years of age: Consult a dentist or doctor.

Other information Store at room temperature

Inactive ingredients
Cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, Bubble Gum Flavor, polysorbate 80, propylene glycol, FDandC Red No. 33, sodium benzoate, sodium phosphate monobasic, sodium saccharin, sorbitol, water, xylitol.

DR.Fresh

Question? Comments?

Toll Free. 1-866-373-7374

comments@defresh.com

visit us online at:

www.drfresh.com

Distributed by:

USA - Dr. Fresh Inc.

Buena Park, CA 90620 USA

Canada - Dr. Fresh Inc. Ontario,

Canada L7C2T4

UK - Grosvenor Consumer Products Limited

25 Gore Road, Burnham Bucks SL1 8AB

www.firefly.us.com

FireFly* and related trademark, names, logos, and patents are the property of Dr.Fresh, Inc. and are registered and/or used in the U.S. and countries around the world.

2010 Dr. Fresh, Inc.

Patent Pending

Made in U.S.A.

Do not use if carton is open or if printed foil seal underneath tube cap is missing or broken.

FIREFLY MOUTHSWOOSH

Anti-Cavity Fluoride Rinse

BLAZIN Bubble Gum Flavor

16 fl oz (473 mL)

IMPORTANT:

Read directions for proper use.

- Sugar-Free

- Alcohol-Free

- With Fluoride


Made in U.S.A.

FIREFLY MOUTH SWOOSH ANTI-CAVITY FLUORIDE RINSE 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-300
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (SODIUM CATION) SODIUM FLUORIDE0.05 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
XYLITOL 
Packaging
#Item CodePackage Description
1NDC:64893-300-0044 mL in 1 TUBE
2NDC:64893-300-01473 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/02/2010
Labeler - Dr. Fresh, Inc. (033059119)
Establishment
NameAddressID/FEIOperations
Dr. Fresh, Inc.033059119manufacture

Revised: 09/2010
 
Dr. Fresh, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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