GUM- sodium fluoride paste, dentifrice

Gum by

Drug Labeling and Warnings

Gum 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

Purpose

Anticavity

INDICATIONS & USAGE

Use: helps in prevention of cavities.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

KEEP OUT OF REACH OF CHILDREN

Children under 2 years of age ask a dentist or physician

INACTIVE INGREDIENT

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.

SPL UNCLASSIFIED SECTION

Distributed by:

Sunstar Americas, In.

Chicago, IL 60630, U.S.A., 

Made in U.S.A.

GUMbrand.com

DOC02399

P13190

PRINCIPAL DISPLAY PANEL

SUNSTAR

G.U.M®CAVITY PROTECTION                                        1746

HEALTHY GUMS. HEALTHY LIFE®                                                DOC02399

Fluoride Toothpaste                                                       P13190

0.85 oz/18 mL/Cont.net 24g

INGREDIENTS AND APPEARANCE

GUM 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52376-036
Route of Administration	DENTAL

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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/01/2013

Labeler - Sunstar Americas, Inc. (025066358)