ORAL DEFENSE FLUORIDE RINSE- sodium fluoride mouthwash

Oral Defense Fluoride Rinse by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients

Sodium Fluoride .05% (0.22% w/v fluoride ion)

Purpose

Anti-cavity

Uses

Aids in the prevention of dental cavities

Warnings

Do not swallow. In case of accidental ingestion, seek medical help or contact a poison control center immediately. Cold weather may cloud this product. Properties are not affected.

Keep out of the reach of children.

Directions

Adults and children 6 years of age and older

• Use once a day, preferably before bedtime, after brushing and flossing thoroughly.

• For mature adults with gum recession, it is beneficial to use an interdental proxy brush (toothpick type plastic brush) to remove all food debris between all teeth.

• Use 10ml (1/3oz) and vigorously swish between the teeth for 1 minute. Spit out. Do not swallow.

• Supervise children over 6 years of age until capable of suing without supervision.

• Consult with a dentist or doctor for use with children under 6 years of age.

• Do not take in food or drink for 30 minutes after application.

Inactive Ingredients

purified water, glycerin, propylene glycol, sorbitol, polysorbate 80, poloxamer 407, flavor, versene, cetylpyridinium chloride, sodium lauroyl sarcosinate, sodium saccharin, sodium hydroxide, citric acid, natamycin, FD and C green #5, FD and C red #33.

Labels

INGREDIENTS AND APPEARANCE

ORAL DEFENSE FLUORIDE RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52644-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.2418 g  in 474 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
NATAMYCIN (UNII: 8O0C852CPO)
MINT (UNII: FV98Z8GITP)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	turquoise (Blue green)	Score
Shape		Size
Flavor	VANILLA (Vanilla Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52644-002-00	474 mL in 1 BOTTLE, PLASTIC
2	NDC: 52644-002-02	60 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/31/2010

Labeler - Oral Defense, LLC (962643164)

Establishment
Name	Address	ID/FEI	Business Operations
Coastal Products Company		782445688	manufacture(52644-002)