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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Phos-Flur® Ortho Defense®

Drug Facts

Active ingredient

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

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

Inactive ingredients

water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40

Other Information

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

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE*

Colgate®

PhosFlur®
Ortho Defense®
Anticavity Fluoride Rinse

IDEAL PROTECTION
WHILE WEARING BRACES

  • ✓ ORTHODONTIST RECOMMENDED
  • ✓ HELPS STRENGTHEN ENAMEL
  • ✓ HELPS PREVENT CAVITIES

GUSHING GRAPE

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT: Read directions for proper use

ADA
Accepted
American
Dental
Association ®

P9895933

Principal Display Panel - 500 mL Bottle Label
PHOS-FLUR ORTHO DEFENSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0126-0138
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0126-0138-46500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/201108/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/15/201108/01/2019
Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 9/2019
Document Id: 4b1f597e-1fe4-455a-9500-5da74b8eae73
Set id: 84de9ca9-7959-4d5f-9bb0-884cee1b8038
Version: 3
Effective Time: 20190911