SENSODYNE PRONAMEL KIDS BUBBLE MINT- sodium fluoride paste, dentifrice

Sensodyne Pronamel by

Drug Labeling and Warnings

Sensodyne Pronamel by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Anticavity

Use

• aids in the prevention of dental cavities.

Warnings

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.

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

Questions or comments?

1-866-844-2797

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.

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)

INGREDIENTS AND APPEARANCE

SENSODYNE PRONAMEL   KIDS BUBBLE MINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0818
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0818-01	1 in 1 CARTON	12/15/2025
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/15/2025

Labeler - Haleon US Holdings LLC (079944263)