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, poloxamer 338, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1

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

Colgate®

PhosFlur®
Ortho Defense®
Anticavity Fluoride Rinse

IDEAL PROTECTION
WHILE WEARING BRACES

✓ ORTHODONTIST RECOMMENDED

✓ HELPS STRENGTHEN ENAMEL

✓ HELPS PREVENT CAVITIES

MINT

ADA
Accepted
American
Dental
Association ®

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT: Read directions for proper use

P9902500

PHOS-FLUR ORTHO DEFENSE 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0126-0135
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLOXAMER 338 (UNII: F75JV2T505)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0126-0135-46	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2011	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/12/2011	08/01/2019

Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 9/2019

Document Id: 8d4d2604-ab31-44fc-a95a-b58d88a74cad

34390-5

Set id: 4ca1ffec-6348-4096-be9d-1232ccdba405

Version: 3

Effective Time: 20190911