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Phos-Flur Ortho Defense by Colgate Oral Pharmaceuticals, Inc.

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 4.42mg in 10mL
Labeler: Colgate Oral Pharmaceuticals, Inc.
NDC Code: 0126-0139

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.

Colgate®
Phos-Flur®
Ortho Defense™

Drug Facts

Active ingredient (in each 10 ml)

Sodium fluoride 4.4 mg

Purpose

Anticavity

Use

aids in the prevention of dental decay

Warnings

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

Directions
adults and children 6 years of age and older
  • use once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters (10 ml mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
children under 6 years of age
  • ask a dentist or physician

Other information

store at controlled room temperature 68-77°F (20-25°C)

Inactive ingredients

D&C red no. 33, flavor, phosphoric acid, polysorbate 20, potassium sorbate, sodium phosphate, sorbitol, water

Questions or comments?

Call toll-free 1-800-962-2345

Colgate Oral
Pharmaceuticals, Inc.

a subsidiary of
Colgate-Palmolive Company
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 473 ml Bottle Label

IMPORTANT: Read directions for proper use

Colgate®

Phos-Flur®

Ortho Defense™
Acidulated Phosphate Fluoride Solution
Anticavity Dental Rinse

#1 Orthodontist Recommended

Ideal protection while wearing braces

Proven to help prevent cavities

Helps prevent white spots

Bubble Gum

ADA
Accepted
American
Dental
Association ®

16 FL OZ (1 PT) 473 ml

P10001723

PHOS-FLUR ORTHO DEFENSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0139
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE4.42 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
POTASSIUM SORBATE 
PHOSPHORIC ACID 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
POLYSORBATE 20 
D&C RED NO. 33 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0126-0139-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/11/2011
Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

Revised: 07/2011
 
Colgate Oral Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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