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Anticavity

Tom's of Maine, Inc.

Tom's OF MAINE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 10mL)

Sodium fluoride 0.0442%

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age.

  • 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 toothpaste
  • Remove cap, fill to 10 ml mark
  • Vigorously swish 10 ml of rinse between your teeth for 1 minute and then spit out
  • Do not swallow the rinse
  • Do not eat or drink for 30 min. after rinsing
  • Instruct children under 12 yrs. 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.

Inactive ingredients

water, glycerin, organic Aloe barbadensis leaf juice, xylitol, sodium phosphate, propanediol, natural flavor, benzoic acid, menthol

Questions?

1-800-FOR-TOMS (1-800-367-8667)

M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

new!

SINCE 1970
Tom's

OF MAINE

ADA
Accepted

American
Dental
Association ®

alcohol-free
natural

ANTICAVITY

strong cavity protection
for a healthy smile

fluoride rinse

juicy mint

473 mL (16 FL OZ)

IMPORTANT: Read
directions for proper use

Anticavity

Anticavity

Sodium Fluoride RINSE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-001
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.46277 mg

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
Xylitol
sodium phosphate
PROPANEDIOL
BENZOIC ACID
Aloe Vera Leaf
MENTHOL
MINT

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51009-001-16 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2010-08-30


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Be sure to consult your doctor before taking any medication!
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