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Gum

Sunstar Americas, Inc.

Gum Fluoride Toothpaste   




FULL PRESCRIBING INFORMATION

Active Ingredient

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

Purpose

Purpose

Anticavity

Uses

Use: helps in prevention of cavities.

Warnings: Keep out of reach of children under six year of age. if more than use for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions-adults and children 2 years of age and older: brush teeth thoroughly, preferably after meals or at least twice a day, or use as directed by a dentist or a physician. To minimize swallowing for children under 6,use only pea-sized amount and supervise the child's brushing.

Children under 2 years of age ask a dentist or physician

Inactive Ingredients: Sorbitol, Silica, Purified Water, Glycerin, PEG-12, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, Cellulose, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin

TWIST OFF CAP AND REMOVE FOIL SEAL. DONOT USE IF FOIL IS NOT INTACT.

Distributed by:

Sunstar Americas, In.

Chicago, IL 60630, U.S.A., 

Made in U.S.A.

GUMbrand.com

DOC02399

P13190

SUNSTAR

G.U.M® CAVITY PROTECTION                                        1746

HEALTHY GUMS. HEALTHY LIFE®                                                DOC02399

Fluoride Toothpaste                                                       P13190

0.85 oz/18 mL/Cont.net 24g

Gum

Gum

Sodium Fluoride PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52376-036
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.24 g

Inactive Ingredients

Ingredient Name Strength
sorbitol
SILICON DIOXIDE
water
GLYCERIN
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
titanium dioxide
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM BENZOATE
SODIUM PHOSPHATE, DIBASIC
saccharin sodium

Product Characteristics

Color
white

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52376-036-02 24 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2013-12-01


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