ORAL DEFENSE- cetylpyridinium chloride mouthwash

Oral Defense by

Drug Labeling and Warnings

Oral Defense 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

Cetylpyridinium Chloride 0.1%

Pupose

Antigingivitus/Anti-Plaque

Uses

• Canker sores

• Dry mouth conditions

• Oral lesions from chemo and radiation therapies

• Diabetes

• Gum irritations and disease

• Lichen Plannus

Warnings

See a dentist if symptoms or conditions persist after regular use.

Keep out of the reach of children

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.

Directions

Healthy Mouth

Rinse with 1 capful after brushing your teeth with Oral Defense toothpaste when needed for breath refreshment and to maintain healthy mouth tissue.

Red, Bleeding gums and inflamed mouth

For best and speedy results use with Oral Defense toothpaste. Use 1 capful after brushing with Oral Defense Toothpaste for 1 minute. If the lesions or sores re in one area, hold the capful of rinse in your mouth over the lesion for 1 minute, or if not possible to hold for 1 minute then use twice, 1 capful for 30 seconds each before spitting out. The most critical time of application is at bedtime, when no food or water is to be consumed after use, as the rinse has ingredients that have a long effective residual throughout the night when healing is best to occur.

Inactive Ingredients

purified water, glycerin, propylene glycol, sorbitol, polysorbate 80, poloxamer 407, mentha piperita (peppermint oil), versene, sodium lauroyl sarcosinate, sodium hydroxide, citric acid, menthol, natamycin, FD and C green #5

Questions or comments

1-800-355-9621

Manufactured Exclusively for Oral Defense, LLC Spokane, WA 99205

Labeling

INGREDIENTS AND APPEARANCE

ORAL DEFENSE 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52644-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	.47 mL  in 474 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
NATAMYCIN (UNII: 8O0C852CPO)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
PEPPERMINT OIL (UNII: AV092KU4JH)
MENTHOL (UNII: L7T10EIP3A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	turquoise (Blue/Green)	Score
Shape		Size
Flavor	MINT (Cool mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52644-001-00	474 mL in 1 BOTTLE, PLASTIC
2	NDC: 52644-001-02	60 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/26/2010

Labeler - Oral Defense, LLC (962643164)

Establishment
Name	Address	ID/FEI	Business Operations
Coastal Products Company		782445688	manufacture(52644-001)