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Sensodyne pronamel kids bubble twist - Medication Information

Product NDC Code 0135-0808
Drug Name

Sensodyne pronamel kids bubble twist

Type Brand
Active Ingredients
Sodium fluoride 1.1 mg/g
Route DENTAL
Dosage Form PASTE
Application Number M022
Labeler Name Haleon US Holdings LLC
Packages
Package NDC Code Description
0135-0808-01 1 tube in 1 carton (0135-0808-01) / 113 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Sodium fluoride 0.254% (0.15% w/v fluoride ion)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, blue 1

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use aids in the prevention of dental cavities.

Purpose

Information about the drug product’s indications for use.
Purpose Anticavity

Spl product data elements

Usually a list of ingredients in a drug product.
Sensodyne Pronamel Kids Bubble Twist sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel FLUORIDE ANTICAVITY TOOTHPASTE new HALEON Sensodyne PRONAMEL KIDS Bubble Twist 24hr Cavity Protection* 2x Stronger Enamel Defense* NET WT 4.0 OZ (113 g) 62000000212226 Carton Front Sensodyne Pronamel Kidz 4.0 oz (113 g).jpg

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other information do not store above 25°C (77°F)

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-866-844-2797 ALWAYS FOLLOW THE LABEL

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API