COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE- sodium fluoride rinse 
Team Technologies, 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 ® Alcohol Free Anticavity Gushing Grape Fluoride Rinse

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®

Phos•Flur ®

Ortho Defense ®

Anticavity Fluoride Rinse

IDEAL PROTECTION

WHILE WEARING BRACES

  1. ORTHODONTIST RECOMMENDED
  2. HELPS STRENGTHEN ENAMEL
  3. 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

Phos Flur Artwork

Front and Back Panels

COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-034(NDC:0126-0034)
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)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
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:67659-034-30100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/01/2017
Labeler - Team Technologies, Inc. (192339703)
Registrant - Team Technologies, Inc. (192339703)
Establishment
NameAddressID/FEIBusiness Operations
Team Technologies, Inc079337800repack(67659-034) , relabel(67659-034)

Revised: 12/2019
Document Id: 9a9d9092-42ff-71af-e053-2995a90acd06
Set id: 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd
Version: 2
Effective Time: 20191226
 
Team Technologies, Inc.