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 Daxal Cosmetics Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

DRUG FACTS

PURPOSE

Anticavity Toothpaste.

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 throughly, 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 - 43 g Tube

INGREDIENTS AND APPEARANCE

MAXIMUM SECURITY 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76001-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76001-002-01	4.25 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2018
2	NDC: 76001-002-02	17 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 76001-002-03	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
4	NDC: 76001-002-04	43 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
5	NDC: 76001-002-05	78 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
6	NDC: 76001-002-06	130 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2018

Labeler - Daxal Cosmetics Private Limited (650497790)

Establishment
Name	Address	ID/FEI	Business Operations
Daxal Cosmetics Private Limited		650497790	manufacture(76001-002)