You are here: Home > Over-the-counter (OTC) Drugs > B > Breathawaymouth Rinse Fresh Mint (Melaleuca, Inc.)

Name:Breathawaymouth Rinse Fresh Mint
Manufacturer:Melaleuca, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BreathAway Mouth Rinse Fresh Mint Content of Label

BREATHAWAY MOUTH RINSE FRESH MINT - cetylpyridinium chloride mouthwash 
Melaleuca, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

BreathAway Mouth Rinse Fresh Mint Content of Label

Active ingredient
Cetylpyridinium chloride 0.07%

Purpose
Antigingivitis/Antiplaque

Uses

  • helps prevent gingivitis
  • helps prevent plaque that leads to gingivitis

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

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: vigorously swish 20 mL (4 teaspoonfuls) between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use.
  • children under 6 years of age: do not use

Inactive ingredients
water, sorbitol, glycerin, PEG-40 hydrogenated castor oil, polysorbate 20, sodium benzoate, flavor, potassium sorbate, citric acid, sodium hydroxide, poloxamer 407, xylitol, zinc citrate, potassium acesulfame, melaleuca alternifolia (tea tree) leaf oil, ethyl menthane carboxamide, commiphora myrrha oil

image of label

image of label

BREATHAWAY  MOUTH RINSE FRESH MINT
cetylpyridinium chloride mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-209
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.3394 g  in 473 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM  
ANHYDROUS CITRIC ACID  
ETHYL MENTHANE CARBOXAMIDE  
GLYCERIN  
MYRRH OIL  
POLOXAMER 407  
POLYOXYL 40 HYDROGENATED CASTOR OIL  
POLYSORBATE 20  
POTASSIUM SORBATE  
SODIUM BENZOATE  
SODIUM HYDROXIDE  
SORBITOL  
TEA TREE OIL  
WATER  
XYLITOL  
ZINC CITRATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54473-209-16 473 mL in 1 BOTTLE None
2 NDC:54473-209-08 237 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 05/02/2011

Labeler - Melaleuca, Inc. (139760102)
Establishment
Name Address ID/FEI Operations
Melaleuca, Inc. 139760102 manufacture

Revised: 04/2011 Melaleuca, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2019 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

OTC Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback