ORAL DEFENSE- sodium fluoride paste, dentifrice

Oral Defense by

Drug Labeling and Warnings

Oral Defense by is a Otc medication manufactured, distributed, or labeled by Oral Defense, Coastal Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Anti-Cavity toothpaste

Active Ingredient

Sodium Fluoride 0.25% (0.14 w/v Fluoride Ion)

Use

Aids in prevention of dental cavities and gingivitis.

Warnings

Children under two years of age: Consult a dentist or physician. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of the reach of children under 6 years of age.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

For maximum benefits, brush for 1 minute at bedtime and use with Oral Defense Fluoride Rinse.

Question and Comments?

1-800-355-9621 1-509-326-6693 Office

Manufactured for: Oral Defense LLC, P.O. Box 8267 Spokane, WA 99203

Patent No. US 6,861,047B

Inactive Ingredients

Sorbitol, Purified Water, Glycerin, Hydrated Silica, Sodium Lauroyl Sarconsinate, Cellulose Gum, Flavor, Titanium Dioxide, Cetylpyridinium Chloride, Citric Acid, Sodium Saccharin, FD&C Blue No. 1, Dehydroacetic Acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAL DEFENSE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52644-003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.14 g  in 118 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
water (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CETYLPYRIDINIUM (UNII: CUB7JI0JV3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

Product Characteristics
Color	blue (blue (FD and C Blue No. 1))	Score
Shape		Size
Flavor	MINT (MINT (Fluoride Toothpaste Flavor Mint))	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52644-003-01	1 in 1 BOX
1	NDC: 52644-003-00	118 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/12/2011

Labeler - Oral Defense (962643164)

Establishment
Name	Address	ID/FEI	Business Operations
Coastal Products Company		782445688	manufacture(52644-003)