93e366a1-23da-4424-83f7-b7a85a3c79c5 — v1

6 Views

Version

v1

Effective date

August 25, 2008

Original packager

Sections captured

7

Identifiers

Document ID
8eea2823-e207-4870-b9f9-25eae9637a7c
Set ID
93e366a1-23da-4424-83f7-b7a85a3c79c5
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

ACTIVE INGREDIENT Sodium fluoride- 0.22% (0.1% w/v fluoride ion)
Inactive Ingredient (1)

Sequence 1

INACTIVE INGREDIENTS Purified Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Poly Ethylene Glycol 1500, Sodium Saccharin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Methyl Paraben, Propyl Paraben. Product of India, Exclusive Distributor: Bob Barker Co. Inc., Phone: 1-800-334-9880. Expires: 3 years from the Date of Mfg. C.No. DNH/COS/DNH/52 Mfg. Date & Batch No. on crimp. 24.06.2009 MAXIMUM SECURITY GEL TOOTHPASTE ACTIVE INGREDIENT: SODIUM FLUORIDE - 0.22 % (0.1% w/v fluoride Ion) SR. NO. INGREDIENTS Treated water Sorbitol Carbopol Sodium lauryl sulphate Flavor Polyethylene glycol 1500 Sodium saccharin Precipitated Silica Sodium Carboxy Methyl Cellulose Methyl Paraben Propyl Paraben
Package Label Principal Display Panel (1)

Sequence 1

Tube Label MAXIMUM SECURITY® GEL TOOTHPASTE NET WT 4.6 0Z.(130g) Tube Label
Purpose (1)

Sequence 1

PURPOSE Anticavity.
Spl Product Data Elements (1)

Sequence 1

Maxixum Security Gel Toothpaste Fluoride Toothpaste SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL CARBOMER HOMOPOLYMER TYPE C SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 1500 SACCHARIN SODIUM SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM METHYLPARABEN PROPYLPARABEN MINT
Spl Unclassified Section (4)

Sequence 1

NET WT 4.6 OZ

Sequence 2

DRUG FACTS:

Sequence 3

USE Helps protect against cavities.

Sequence 4

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.
Warnings (1)

Sequence 1

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.