Drug Facts

Active ingredient

Sodium Fluoride - 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

Helps protect against cavities.

Warnings

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults & Children 6 years of age & older:	Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children 2 to 6 years:	Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years:	Ask a dentist or physician.

Inactive ingredients

Sorbitol, Water, Hydrated Silica, Glycerin, Cellulose Gum, Sodium Lauryl Sulfate, Polyethylene Glycol, Sodium Benzoate, Flavor, Sodium Saccharin

Dist. by Bob Barker Co. Inc. Fuquay-Varina, NC 27526

PRINCIPAL DISPLAY PANEL - 24 g Tube Label

MAXIMUM®
SECURITY

ANTICAVITY
GEL TOOTHPASTE

Sodium Fluoride 0.22%

Fresh Mint Flavor

NET WT 0.85 OZ. (24 g)

PRINCIPAL DISPLAY PANEL - 24 g Tube Label

MAXIMUM SECURITY
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53247-122
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	2.2 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Polyethylene Glycol 1600 (UNII: 1212Z7S33A)
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53247-122-01	4.3 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2008
2	NDC:53247-122-02	17 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
3	NDC:53247-122-03	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
4	NDC:53247-122-04	43 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
5	NDC:53247-122-05	78 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	10/25/2023
6	NDC:53247-122-06	130 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M021	01/01/2008

Labeler - Bob Barker Company Inc. (058525536)