SMILEGUARD SPIDER SENSE SPIDER-MAN BUBBLEGUM- sodium fluoride mouthwash

SmileGuard Spider Sense Spider-Man Bubblegum by

Drug Labeling and Warnings

SmileGuard Spider Sense Spider-Man 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

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

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

INGREDIENTS AND APPEARANCE

SMILEGUARD SPIDER SENSE SPIDER-MAN BUBBLEGUM 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-441
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: 64893-441-08	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)