Colgate® Phos-Flur® Ortho Defense™

Drug Labeling and Warnings

Drug Details [pdf]

PHOS-FLUR ORTHO DEFENSE- sodium fluoride rinse 
Colgate Oral Pharmaceuticals, 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.

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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

PRINCIPAL DISPLAY PANEL - 473 ml Bottle Label
PHOS-FLUR ORTHO DEFENSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0126-0139
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE4.42 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0126-0139-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/11/201108/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/11/201108/01/2019
Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 9/2019
Document Id: d6e4bfcb-d282-4c89-88b8-40dda793a6b6
Set id: 594f3394-47ee-4c06-b0ce-494a6367895a
Version: 2
Effective Time: 20190911