SENSODYNE PRONAMEL KIDS BERRY TWIST- sodium fluoride paste

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 0.254% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

• aids in the prevention of dental cavities.

Warnings

Keep out of the 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 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, red 30

Questions or comments?

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

FLUORIDE ANTICAVITY TOOTHPASTE

new HALEON

Sensodyne PRONAMEL

KIDS

Berry Twist

24hr Cavity Protection*

2x Stronger Enamel Defense**

NET WT 4.0 OZ (113 g)

62000000212335 Front Label

INGREDIENTS AND APPEARANCE

SENSODYNE PRONAMEL   KIDS BERRY TWIST
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0809
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	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)
D&C RED NO. 30 (UNII: 2S42T2808B)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0809-01	1 in 1 CARTON	01/06/2025
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0809-02	23 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/06/2025

Labeler - Haleon US Holdings LLC (079944263)