SMILEGUARD STRAWBERRY SHORTCAKE BUBBLEGUM- sodium fluoride mouthwash 
Dr. Fresh, LLC

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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Smile Guard Strawberry Shortcake Bubble Gum Mouthwash

Active Ingredient

Sodium Fluoride 0.05%

Purpose

Anti-cavity

Use

Aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

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

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

Product Label

SmileGuard

Strawberry Shortcake
Bubble Gum
Mouthwash

Sugar and Alcohol Free with Fluoride!

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

Strawberry Shortcake Mouthwash
SMILEGUARD STRAWBERRY SHORTCAKE BUBBLEGUM 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-440
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64893-440-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/09/201101/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/09/201101/01/2015
Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021
Document Id: d6dfb202-27a2-4ff0-a025-eda358ccad35
Set id: 484bfa53-8147-4775-8f4c-98c99053e999
Version: 6
Effective Time: 20210922
 
Dr. Fresh, LLC