drug facts

drug facts
SPL v2
SPL
SPL Set ID 41b1e626-e79b-d638-e063-6394a90a1f5b
Route
dental
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.1 mg)
Inactive Ingredients
water sorbitol hydrated silica glycerin polyethylene glycol 400 cocamidopropyl betaine xanthan gum saccharin sodium sodium hydroxide fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-15

Purpose

Anticavity

Description

Sodium fluoride 0.245% (0.15% w/v fluoride ion)


Medication Information

Purpose

Anticavity

Directions
  • adults and children 2 years of age and older:
    • brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
  • children under 2 years of age:Consult a dentist or doctor.
Other Information
  • do not store above 25°C (77°F)
Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, blue 1

Description

Sodium fluoride 0.245% (0.15% w/v fluoride ion)

Principal Display Panel

new look

SENSODYNE PRONAMEL

KiDS Bubble Mint

FLUORIDE ANTICAVITY TOOTHPASTE

24hr Cavity Protection*

2X Stronger Enamel Defense**

NET WT 4.0 OZ (113 g)

Use
  • aids in the prevention of dental cavities.
Active Ingredient

Sodium fluoride 0.245% (0.15% w/v fluoride ion)

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE PRONAMEL

Bubble Mint KiDS

#1 DENTIST RECOMMENDED TOOTHPASTE FOR PROTECTING AND STRENGTHENING ENAMEL

Adults | Kids

Kids enamel is 50% thinner

Kids enamel is 50% thinner vs an Adults

This makes kids’ teeth more vulnerable to everyday sugar & dietary acids like fruit and juices.

24hr Cavity Protection*

2x Stronger Enamel Defense**

Pronamel Kidsstrengthens and protects developing enamel. Strong enamel is the best defense against cavities and enamel wear.

Pronamel for Kidsprovides:

24 hour Cavity Protection*

2x Stronger Enamel Defense**

Natural Flavors

Gluten Free

Vegan Friendly***

Sugar, SLS & Paraben Free

*Follow a healthy diet and brush twice daily. (Level of protection may decrease between brushing.) **Protection from sugar acids vs your mouth’s natural defenses. ***Contains no animal products and animal derived products.

Questions Or Comments?

1-866-844-2797

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose

Anticavity

Directions
  • adults and children 2 years of age and older:
    • brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
  • children under 2 years of age:Consult a dentist or doctor.
Other Information (Other information)
  • do not store above 25°C (77°F)
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, blue 1

Principal Display Panel

new look

SENSODYNE PRONAMEL

KiDS Bubble Mint

FLUORIDE ANTICAVITY TOOTHPASTE

24hr Cavity Protection*

2X Stronger Enamel Defense**

NET WT 4.0 OZ (113 g)

Use
  • aids in the prevention of dental cavities.
Active Ingredient (Active ingredient)

Sodium fluoride 0.245% (0.15% w/v fluoride ion)

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE PRONAMEL

Bubble Mint KiDS

#1 DENTIST RECOMMENDED TOOTHPASTE FOR PROTECTING AND STRENGTHENING ENAMEL

Adults | Kids

Kids enamel is 50% thinner

Kids enamel is 50% thinner vs an Adults

This makes kids’ teeth more vulnerable to everyday sugar & dietary acids like fruit and juices.

24hr Cavity Protection*

2x Stronger Enamel Defense**

Pronamel Kidsstrengthens and protects developing enamel. Strong enamel is the best defense against cavities and enamel wear.

Pronamel for Kidsprovides:

24 hour Cavity Protection*

2x Stronger Enamel Defense**

Natural Flavors

Gluten Free

Vegan Friendly***

Sugar, SLS & Paraben Free

*Follow a healthy diet and brush twice daily. (Level of protection may decrease between brushing.) **Protection from sugar acids vs your mouth’s natural defenses. ***Contains no animal products and animal derived products.

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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