MAXIMUM SECURITY- sodium fluoride gel, dentifrice

Maximum Security by

Drug Labeling and Warnings

Maximum Security by is a Otc medication manufactured, distributed, or labeled by Bob Barker Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Water, Sorbitol, Sodium Lauryl Sulfate, Carbomer, Sodium Saccharin, Sodium Hydroxide, PEG-40 Hydrogenated Castor Oil, Flavor, Sodium Benzoate

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

MAXIMUM
SECURITY®

ANTICAVITY
GEL TOOTHPASTE

Sodium Fluoride 0.22%

Fresh Mint Flavor
NET WT 4.6 OZ. (130 g)

INGREDIENTS AND APPEARANCE

MAXIMUM SECURITY 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53247-119
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Sodium Hydroxide (UNII: 55X04QC32I)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53247-119-01	4.3 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2008
2	NDC: 53247-119-02	17 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
3	NDC: 53247-119-03	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
4	NDC: 53247-119-04	43 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
5	NDC: 53247-119-05	78 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
6	NDC: 53247-119-06	130 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/01/2008

Labeler - Bob Barker Company Inc. (058525536)