MAXIMUM SECURITY- sodium fluoride gel, dentifrice
Bob Barker Company 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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Maximum Security®

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 of 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

Purified Water, Sorbitol, Sodium Lauryl Sulphate, Carbopol, Flavor, Sodium Hydroxide, Sodium Saccharin, Ethylene Diamine Tetra Acetic Acid, Kathon CG.

PRINCIPAL DISPLAY PANEL - 4.25 g Packet Label

MAXIMUM
SECURITY®

GEL TOOTHPASTE

NET WT .15 OZ. (4.25g)

PRINCIPAL DISPLAY PANEL - 4.25 g Packet Label

MAXIMUM SECURITY
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53247-112
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Hydroxide (UNII: 55X04QC32I)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53247-112-01	4.3 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2008	12/24/2019
2	NDC:53247-112-02	17 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/24/2019
3	NDC:53247-112-03	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/24/2019
4	NDC:53247-112-04	43 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/24/2019
5	NDC:53247-112-05	78 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/24/2019
6	NDC:53247-112-06	130 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/24/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/01/2008	12/24/2019

Labeler - Bob Barker Company Inc. (058525536)

Revised: 12/2019

Document Id: d39a8f32-50a8-4241-8081-dde601b54ee7

Set id: a062ffb2-6cb2-4121-8baa-4d59ae55086c

Version: 2

Effective Time: 20191226

Bob Barker Company Inc.