GUM CAVITY PREVENTION FLUORIDE MINT- sodium fluoride paste, dentifrice
Sunstar Americas, Inc.

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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GUM Cavity Prevention Fluoride Toothpaste Mint

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)

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

image description

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

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

Ingredient Name	Strength
Inactive Ingredients
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 (UNII: K679OBS311)
METHYLPARABEN (UNII: A2I8C7HI9T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52376-086-05	24 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2018	11/04/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/01/2018	11/04/2022

Labeler - Sunstar Americas, Inc. (025066358)

Name	Address	ID/FEI	Business Operations
Establishment
Sunstar Americas, Inc.		025066358	manufacture(52376-086)

Revised: 11/2022

Document Id: ecacd6de-932e-3910-e053-2a95a90a361b

Set id: 48236fcc-bb05-4732-888b-a7d9a4b9b4e2

Version: 3

Effective Time: 20221104

Sunstar Americas, Inc.