GUM CAVITY PREVENTION FLUORIDE MINT- sodium fluoride paste, dentifrice

GUM Cavity Prevention Fluoride Mint by

Drug Labeling and Warnings

GUM Cavity Prevention Fluoride Mint by is a Otc medication manufactured, distributed, or labeled by Sunstar Americas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps in the prevention of dental cavities

Warnings

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

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

Directions

• Adults and children 2 years of age and older:

  Brush teeth thoroughly, preferably after each meal or at least

  twice a day, or as directed by a dentist or doctor.

• Children under 6 years of age:

  Instruct in good brushing and rinsing habits (to minimize swallowing).

  Supervise children as necessary until capable of using without supervision.

• Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

Sorbitol, Water, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Flavor, Xanthan Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Cellulose Gum, Methylparaben

Questions?

1-800-528-8537 Mon-Fri (7am-6 pm CST)

SPL UNCLASSIFIED SECTION

SUNSTAR

Manufactured by: Sunstar Americas, Inc., 301 E. Central Road, Schaumburg, IL 60195, U.S.A. TBE000013Z

GUMbrand.com

TWIST OFF CAP AND REMOVE SEAL.

DO NOT USE IF SEAL IS NOT INTACT.

Packaging

INGREDIENTS AND APPEARANCE

GUM CAVITY PREVENTION FLUORIDE MINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52376-086
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52376-086-05	24 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/01/2018

Labeler - Sunstar Americas, Inc. (025066358)