COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE- sodium fluoride rinse

Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride by

Drug Labeling and Warnings

Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc., Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-034(NDC:0126-0034)
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)
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
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67659-034-30	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/01/2017

Labeler - Team Technologies, Inc. (192339703)

Registrant - Team Technologies, Inc. (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
Team Technologies, Inc		079337800	repack(67659-034) , relabel(67659-034)