Thomas & Friends Toothpaste

Thomas & Friends Toothpaste
SPL v3
SPL
SPL Set ID 16942293-8df7-4a28-82b0-6eb4c828dc4b
Route
DENTAL
Published
Effective Date 2018-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (243 mg)
Inactive Ingredients
Sorbitol Silicon Dioxide Water Polyethylene Glycol 1500 Xylitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Form Benzyl Alcohol Sodium Benzoate Saccharin Sodium Sodium Phosphate, Tribasic, Anhydrous Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-05-09

Description

Sodium Fluoride 0.243% (0.15% w/v Fluoride Ion)

Purpose

Anticavity Toothpaste


Medication Information

Purpose

Anticavity Toothpaste

Description

Sodium Fluoride 0.243% (0.15% w/v Fluoride Ion)

Uses

Helps protect teeth against cavities.

Section 42229-5

BUBBLE GUM GOMME À BULLES

ANTICAVITY FLUORIDE TOOTHPASTE DENTIFRICE ANTICARIE AU FLUORURE

make brushing fun!®

For more oral care information,

visit us at / Pour d’autres

renseignements, visitez:

www.brushbuddies.com

DISTR. BY/PAR NORTHERN NATIONAL

SALES INC. TORONTO, ON, M9M 1M7

C.No. DNH/COS/DNH/52

©2017 HIT Entertainment Limited. HIT and the HIT logo are trademarks of HIT Entertainment Limited.

© 2017 Gullane (Thomas) Limited.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

If more than used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center immediately.

Section 53413-1

QUESTIONS? COMMENTS? / COMMENTAIRES?

1-877-274-8358 (U.S.A.)

1-909-434-0911 (INTERNATIONAL)

1-888-635-5337 (CANADA)

Packaging

Directions

Adults and children 6 years of age and older:

  • Brush teeth thoroughly after meals or at least twice a day. Use directed by a dentist.
  • Do not swallow.
  • To minimize swallowing, use a pea-sized amount in children under 6 years of age.
  • Supervise children’s brushing until good brushing habit are established.
  • Children under 2 years of age: Ask a dentist.
Drug Facts

Other Information

Store at room temperature.

Active Ingredients

Sodium Fluoride 0.243% (0.15% w/v Fluoride Ion)

Inactive Ingredients

Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Blue #1, FD&C Red #40.


Structured Label Content

Uses

Helps protect teeth against cavities.

Section 42229-5 (42229-5)

BUBBLE GUM GOMME À BULLES

ANTICAVITY FLUORIDE TOOTHPASTE DENTIFRICE ANTICARIE AU FLUORURE

make brushing fun!®

For more oral care information,

visit us at / Pour d’autres

renseignements, visitez:

www.brushbuddies.com

DISTR. BY/PAR NORTHERN NATIONAL

SALES INC. TORONTO, ON, M9M 1M7

C.No. DNH/COS/DNH/52

©2017 HIT Entertainment Limited. HIT and the HIT logo are trademarks of HIT Entertainment Limited.

© 2017 Gullane (Thomas) Limited.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

If more than used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center immediately.

Section 53413-1 (53413-1)

QUESTIONS? COMMENTS? / COMMENTAIRES?

1-877-274-8358 (U.S.A.)

1-909-434-0911 (INTERNATIONAL)

1-888-635-5337 (CANADA)

Purpose

Anticavity Toothpaste

Packaging

Directions

Adults and children 6 years of age and older:

  • Brush teeth thoroughly after meals or at least twice a day. Use directed by a dentist.
  • Do not swallow.
  • To minimize swallowing, use a pea-sized amount in children under 6 years of age.
  • Supervise children’s brushing until good brushing habit are established.
  • Children under 2 years of age: Ask a dentist.
Drug Facts

Other Information

Store at room temperature.

Active Ingredients

Sodium Fluoride 0.243% (0.15% w/v Fluoride Ion)

Inactive Ingredients

Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Blue #1, FD&C Red #40.


Advanced Ingredient Data


Raw Label Data

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