SMILEGUARD STRAWBERRY SHORTCAKE BUBBLEGUM- sodium fluoride mouthwash

SmileGuard Strawberry Shortcake Bubblegum by

Drug Labeling and Warnings

SmileGuard Strawberry Shortcake Bubblegum by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

SMILEGUARD STRAWBERRY SHORTCAKE BUBBLEGUM 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-440
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64893-440-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/09/2011

Labeler - Dr. Fresh LLC (117376803)