5917 Bubble Fresh Toothpaste.85 Oz.

SPL v1

SPL

SPL Set ID 2a2f5ed9-31ec-f6c8-e063-6394a90a44d6

Route

DENTAL

Published

Effective Date 2025-01-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (220 mg)

Inactive Ingredients

Hydrated Silica Polyethylene Glycol 1450 Sorbitol Saccharin Sodium Sodium Lauryl Sulfate Sodium Benzoate Water Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-15

Description

Sodium Fluoride 0.22%

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.22%

Label

5917 Bubble Fresh Toothpaste with Fluoride

Use(s)

Helps protect against cavities

Section 55106-9

Sodium Fluoride 0.22%

Warnings

Do Not Swallow

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: To minimize swallowing, use a pea size amount and supervise child's brushing and rinsing until good habits are established.

• Children under 2 years: Use as directed by a dentist or physician

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Other Information

Store between 15º - 35ºC (59º - 95ºF)

Inactive Ingredients

Carboxymethylcellulose Sodium, Flavor (Bubble Gum Flavor), Hydrated Silica Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

Keep Our to Reach of Children Under 6 Years of Age

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Structured Label Content

Label

5917 Bubble Fresh Toothpaste with Fluoride

Use(s)

Helps protect against cavities

Section 55106-9 (55106-9)

Sodium Fluoride 0.22%

Purpose

Anticavity

Warnings

Do Not Swallow

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: To minimize swallowing, use a pea size amount and supervise child's brushing and rinsing until good habits are established.

• Children under 2 years: Use as directed by a dentist or physician

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Other Information

Store between 15º - 35ºC (59º - 95ºF)

Inactive Ingredients

Carboxymethylcellulose Sodium, Flavor (Bubble Gum Flavor), Hydrated Silica Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

Keep Our to Reach of Children Under 6 Years of Age (Keep our to reach of children under 6 years of age)

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Advanced Ingredient Data

[{"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 1450", "unii": "OJ4Z5Z32L4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "220", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Label": "5917 Bubble Fresh Toothpaste with Fluoride", "Use(s)": "Helps protect against cavities", "55106-9": "Sodium Fluoride 0.22%", "Purpose": "Anticavity", "Warnings": "Do Not Swallow", "Directions": "• Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. • Children under 6 years: To minimize swallowing, use a pea size amount and supervise child's brushing and rinsing until good habits are established. • Children under 2 years: Use as directed by a dentist or physician", "Questions?": "1-888-396-2739 Monday - Friday 9AM - 5PM EST", "Other Information": "Store between 15º - 35ºC (59º - 95ºF)", "Inactive Ingredients": "Carboxymethylcellulose Sodium, Flavor (Bubble Gum Flavor), Hydrated Silica Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol", "Keep our to reach of children under 6 years of age": "If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:20.158562 · Updated: 2026-03-14T23:06:59.037711