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OrthoWash

3M ESPE Dental Products


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 10ml)

0.044% Sodium fluoride in an acidulated phosphate solution

Purpose

Anticavity

Use

aids in the prevention of dental decay

Warnings

Keep out of reach of children. If pregnant or breast-feeding, ask a health professional

before use. 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 of rinse between your teeth for 1 minute and 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:

  • consult a dentist or doctor

Other information

do not freeze or expose to extreme heat

Inactive ingredients

water, glycerin, flavoring, sodium benzoate, sodium phosphate, phosphoric acid, FD&C Red #40, FD&C Blue #1

Questions or comments?

call toll free at 1-800-634-2249

Principal Display Panel – Box Label

Grape

NDC 48878-3215-5

3M ESPE

OrthoWash™

Sodium Fluoride in an Acidulated Phosphate Solution

Daily Fluoride Treatment Rinse

Helps prevent tooth decay

Helps prevent white spots

And decay around braces

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

16 fl oz (480ml)

Principal Display Panel – Box Label

Strawberry

NDC 48878-3214-5

3M ESPE

OrthoWash™

Sodium Fluoride

in an Acidulated

Phosphate Solution

Daily Fluoride

Treatment Rinse

Helps prevent tooth decay

Helps prevent white spots

And decay around braces

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

16 fl oz

(480ml)

OrthoWash

sodium fluoride RINSE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48878-3215
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.44 mg

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
SODIUM BENZOATE
sodium phosphate
phosphoric acid
FD&C RED NO. 40
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 480 in 1 BOTTLE, PLASTIC
2 NDC:48878-3215-5 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2002-04-01


OrthoWash

sodium fluoride RINSE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48878-3214
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.44 mg

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
SODIUM BENZOATE
sodium phosphate
phosphoric acid
FD&C RED NO. 40

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 480 in 1 BOTTLE, PLASTIC
2 NDC:48878-3214-5 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2002-04-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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