BEYOND ANTISEPTIC MOUTHWASH- cetylpyridinium chloride, sodium fluoride liquid

Beyond Antiseptic Mouthwash by

Drug Labeling and Warnings

Beyond Antiseptic Mouthwash by is a Otc medication manufactured, distributed, or labeled by BEYOND TECHNOLOGY CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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DRUG FACTS

Active Ingredients

Cetylpyridinium chloride 0.1%

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Antiplaque/Antigingivitis

Anticavity

Use

• Helps prevent and reduce plaque and gingivitis
• Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums
• Aids in the prevention of dental cavities
  

Warnings

STOP USE

• Stop use and ask a dentist if symptoms persist or condition worsens after regular use.
  

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years of age and older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day for 30 seconds.
• Do not swallow.
• Children 6 years to under 12 years of age: supervise use.
• When used after brushing, rinse mouth with water first.
• Children under 6 years of age: do not use.
  

Other Information

• This rinse is not intended to replace brushing or flossing.
• Do not use if safety seal is broken or missing.
• Store in a cool, dry place.
  

Inactive ingredients

Water, alcohol 15%, sorbitol solution, propylene glycol, hydrogenated caster oil, flavor, sodium benzoate, sodium saccharin, menthol carboxamide, tea tree oil, FD and C yellow no. 6

Questions?

1-888-502-5528 M-F 8:30 a.m. - 5:00 p.m. PST

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Distributed by:

BEYOND Dental and Health USA

Stafford, TX 77477 USA

2007 Beyond Dental and Health Inc.

www.360oralcare.com

Principal Display Panel

Antiseptic Mouthwash

Kills Germs for 12 Hour Protection

Fights plaque and gingivitis

Restores minerals to strengthen enamel

Prevents cavities and tooth decay

Lasting breath protection

Refreshing citrus flavor

IMPORTANT: Read directions for proper use.

12 FL Oz (355 mL)

INGREDIENTS AND APPEARANCE

BEYOND ANTISEPTIC MOUTHWASH 
cetylpyridinium chloride, sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42199-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	.1 mg  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.05 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MENTHOL (UNII: L7T10EIP3A)
TEA TREE OIL (UNII: VIF565UC2G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color		Score
Shape		Size
Flavor	CITRUS (Citrus Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42199-002-02	355 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	10/05/2007

Labeler - BEYOND TECHNOLOGY CORP. (653759626)

Establishment
Name	Address	ID/FEI	Business Operations
BEYOND TECHNOLOGY CORP.		653759626	manufacture(42199-002)