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.

USE

Helps protect against cavities.

WARNINGS

Keep out of 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 physician.
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, Carbopol, Sodium Lauryl Sulfate, Flavor, Polyethylene Glycol 1500, Sodium Saccharin, Precipitated Silica, Sodium Carboxymethyl Cellulose, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL - 78 g Tube Label

MAXIMUM
SECURITY ®

GEL TOOTHPASTE

NET WT. 2.75 OZ. (78 g)

Principal Display Panel - 78 g Tube Label

MAXIMUM SECURITY
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53247-109
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)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53247-109-01	4.3 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2008	12/01/2019
2	NDC:53247-109-02	17 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019
3	NDC:53247-109-03	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019
4	NDC:53247-109-04	43 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019
5	NDC:53247-109-05	78 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019
6	NDC:53247-109-06	130 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019

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

Labeler - Bob Barker Company Inc. (058525536)

Revised: 2/2020

Document Id: 9eede347-69fc-6efd-e053-2995a90a9d8d

Set id: ba662265-3958-40e4-b839-3f76dd25e49c

Version: 3

Effective Time: 20200219

Bob Barker Company Inc.