Thomas & Friends Toothpaste

SPL v1

SPL

SPL Set ID 04475db4-5845-4198-beb6-0821b6193931

Route

DENTAL

Published

Effective Date 2018-08-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.76 g)

Inactive Ingredients

Sorbitol Water Silicon Dioxide Sodium Lauryl Sulfate Xylitol Carboxymethylcellulose Sodium, Unspecified Form Sodium Benzoate Xanthan Gum Saccharin Sodium Rose Bengal Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-08-16

Description

Sodium Monofluorophosphate-0.76%

Purpose

Anticavity Toothpaste

Medication Information

Purpose

Anticavity Toothpaste

Description

Sodium Monofluorophosphate-0.76%

Uses

Helps protect teeth against cavities.

Section 42229-5

BUBBLE GUM

ANTICAVITY FLUORIDE TOOTHPASTE

Make brushing fun!®

QUESTIONS OR COMMENTS?

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

1-909-434-0911 (INTERNATIONAL)

ONTARIO, CA 91761

DESIGNED IN U.S.A.

MADE IN CHINA

DISTRIBUTED BY ASHTEL STUDIOS INC.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Warning

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

Packaging

Directions

Adults and children 6 years of age and older:

Brush teeth thoroughly after meals or at least twice a day. Use as 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 Monofluorophosphate-0.76%

Inactive Ingredients

Sorbitol, Water, Silica, Sodium Lauryl Sulfate, Xylitol, Flavor, CMC Sodium Carboxymethyl Cellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red

Structured Label Content

Uses

Helps protect teeth against cavities.

Section 42229-5 (42229-5)

BUBBLE GUM

ANTICAVITY FLUORIDE TOOTHPASTE

Make brushing fun!®

QUESTIONS OR COMMENTS?

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

1-909-434-0911 (INTERNATIONAL)

ONTARIO, CA 91761

DESIGNED IN U.S.A.

MADE IN CHINA

DISTRIBUTED BY ASHTEL STUDIOS INC.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Purpose

Anticavity Toothpaste

Warning

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

Packaging

Directions

Adults and children 6 years of age and older:

Brush teeth thoroughly after meals or at least twice a day. Use as 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 Monofluorophosphate-0.76%

Inactive Ingredients

Sorbitol, Water, Silica, Sodium Lauryl Sulfate, Xylitol, Flavor, CMC Sodium Carboxymethyl Cellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.76", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSE BENGAL SODIUM", "unii": "956575SN5L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps protect teeth against cavities.", "42229-5": "BUBBLE GUM ANTICAVITY FLUORIDE TOOTHPASTE Make brushing fun!® QUESTIONS OR COMMENTS? 1-877-274-8358 (U.S.A.) 1-909-434-0911 (INTERNATIONAL) ONTARIO, CA 91761 DESIGNED IN U.S.A. MADE IN CHINA DISTRIBUTED BY ASHTEL STUDIOS INC.", "50565-1": "KEEP OUT OF REACH OF CHILDREN.", "Purpose": "Anticavity Toothpaste", "Warning": "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 as 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.", "Other Information": "Store at room temperature.", "Active Ingredients": "Sodium Monofluorophosphate-0.76%", "Inactive Ingredients": "Sorbitol, Water, Silica, Sodium Lauryl Sulfate, Xylitol, Flavor, CMC Sodium Carboxymethyl Cellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:37.692071 · Updated: 2026-03-14T22:55:14.803903