Sensodyne Pronamel

Manufacturer
Haleon US Holdings LLC
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:22:57

Label at a glance#

ProductSensodyne Pronamel Kids Bubble Mint
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.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)

Sensodyne Pronamel Kids Bubble Mint 4 oz
Sensodyne Pronamel Kids Bubble Mint 4 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0818-01Sensodyne PronamelKids Bubble Mint113 g in 1 TUBEPASTE, DENTIFRICE1132
0135-0818-01Sensodyne PronamelKids Bubble Mint1 in 1 CARTONPASTE, DENTIFRICE12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-08180135-0818-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensodyne Pronamel Kids Bubble MintSODIUM FLUORIDEHaleon US Holdings LLC41b1e626-e79b-d638-e063-6394a90a1f5b2025-12-15WarningsExact identifier
ndc (package): 0135-0818-01
ndc (product): 0135-0818
ndc11 (package): 00135081801
spl id: 4394cf17-0793-a5c9-e063-6294a90a73c0
spl set id: 41b1e626-e79b-d638-e063-6394a90a1f5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.