Phos-Flur Ortho Defense description, usages, side effects, indications, overdosage, supplying and lots more!

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Phos-Flur Ortho Defense

Colgate Oral Pharmaceuticals, Inc.

Colgate Phos-Flur Ortho Defense™


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Phos-Flur Ortho Defense 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

Phos-Flur Ortho Defense

Phos-Flur Ortho Defense

SODIUM FLUORIDE RINSE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0126-0139
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 4.42 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
POTASSIUM SORBATE
phosphoric acid
Sodium Phosphate, Monobasic, Monohydrate
POLYSORBATE 20
D&C RED NO. 33

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0126-0139-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-02-11


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Be sure to consult your doctor before taking any medication!
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