SmileGuard Spider Sense Spider-Man Bubblegum

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.05mL in 100mL
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-441

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.

Smile Guard Spider Sense SpiderMan Bubble Gum Mouthwash

Active Ingredient

Sodium Fluoride 0.05%

Purpose

Anti-cavity

Use

Aids in the prevention of dental cavities

Warnings

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

Keep out of reach of children.

Directions

Adults and children ages 6 years and older: Use twice a day after brushing your teeth with a toothpaste. Pour 10 milliliters, do not fill above 10mL mark. Rinse 30 seconds with 10mL morning and night. Do not swallow.

Other information
  • Do not use if safety seal is broken or missing
  • Store at room temperature

Inactive Ingredients

Citric acid, Cetylpyridinium chloride, Flavor, Disodium EDTA, Disodium phosphate, FDandC Blue #1, Propylene Glycol, Poloxamer 407, Polysorbate 80, Purified water, Sorbitol, Sodium Phosphate, Sucralose, Xylitol


Distributed by: Dr. Fresh, Inc.

Dr. Fresh, Inc. Buena Park, CA 90620, USA

Canada- Dr. Fresh Inc Ontario, Canada L7C2T4

UK-Grosvenor Consumer Products Ltd
(Dr. Fresh UK)
268 Bath Road
Slough Berkshire SLI 4DX

Customer Service Info:
Questions? Comments?

Toll-Free 1-866-373-7374

UK AND IRL: +44(0)1753-725365

comments@drfresh.com
www.drfresh.co.uk

SmileGuard and related trademarks, names, logos, and patents are the property of Dr. Fresh, Inc and are registered and/or used in the US and countries around the world
2011 Dr. Fresh, Inc.


Product Label

SmileGuard

Spider-Sense
Spider-Man
Sugar and Alcohol Free with Fluoride!
Bubble Gum
Mouthwash

Made in USA
8FL. oz. (237mL)


SMILEGUARD SPIDER SENSE SPIDER-MAN BUBBLEGUM 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-441
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.05 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
CETYLPYRIDINIUM CHLORIDE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
PROPYLENE GLYCOL 
POLOXAMER 407 
POLYSORBATE 80 
WATER 
SORBITOL 
SODIUM PHOSPHATE 
SUCRALOSE 
XYLITOL 
Packaging
#Item CodePackage Description
1NDC:64893-441-08237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/09/2011
Labeler - Dr. Fresh, Inc. (033059119)

Revised: 12/2011
 
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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