THOMAS AND FRIENDS- sodium fluoride paste, dentifrice

Thomas and Friends by

Drug Labeling and Warnings

Thomas and Friends by is a Otc medication manufactured, distributed, or labeled by Ashtel Studios, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose

Anticavity Toothpaste

Uses

Helps protect teeth against cavities.

Warning

KEEP OUT OF REACH OF CHILDREN

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.

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.

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.

Other Information

Store at room temperature.

QUESTIONS

QUESTIONS? COMMENTS? / COMMENTAIRES?
1-877-274-8358 (U.S.A.)
1-909-434-0911 (INTERNATIONAL)
1-888-635-5337 (CANADA)

SPL UNCLASSIFIED SECTION

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.

Packaging

INGREDIENTS AND APPEARANCE

THOMAS AND FRIENDS 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-015
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	243 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-015-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	05/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/09/2018

Labeler - Ashtel Studios, Inc. (148689180)