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Aquafresh extreme clean pure breath action - Medication Information

Product NDC Code 0135-0604
Drug Name

Aquafresh extreme clean pure breath action

Type Brand
Active Ingredients
Sodium fluoride 1.15 mg/g
Route DENTAL
Dosage Form PASTE
RxCUI drug identifier 1044547
Application Number M022
Labeler Name Haleon US Holdings LLC
Packages
Package NDC Code Description
0135-0604-01 1 tube in 1 carton (0135-0604-01) / 158.8 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 0.25% (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: apply toothpaste onto a toothbrush 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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, iron oxides, red 30, 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.
Aquafresh Extreme Clean Pure Breath Action sodium fluoride WATER HYDRATED SILICA SORBITOL GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE XANTHAN GUM TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM ZINC CHLORIDE FERRIC OXIDE YELLOW D&C RED NO. 30 FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION fresh mint

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 NDC 0135-0604-01 Aquafresh ® triple protection® fluoride toothpaste pure breath action Sugar Acid Protection** from Fluoride EXTREME CLEAN ® WITH MICRO-ACTIVE FOAMING ACTION + WHITENING for 80% cleaner, purer breath* NET WT 5.6 OZ (158.8g ) fresh mint Aquafresh ® Extreme Clean ® Pure Breath Action toothpaste creates micro-active foam which seeks out hard to reach places and rinses clear to leave your teeth clean and smooth. It neutralizes bad breath odors for 80% cleaner, purer breath.* Take the Feeling of Clean to the Extreme! ® **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack. triple protection ® healthy gums† strong teeth fresh breath †with twice daily brushing *immediately after brushing versus a zinc free toothpaste ALWAYS FOLLOW THE LABEL Trademarks are owned by or licensed to the GSK group of companies. ©2015 GSK group of companies or its licensor. All rights reserved. GSK Consumer Healthcare Warren, NJ 07059 1-800-897-5623 105483XA 105483XA_Aquafresh Extreme Clean pure breath_5.6 oz.JPG

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 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? Call toll-free 1-800-897-5623

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product, if irritation occurs discontinue use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store below 30°C (86°F)

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 When using this product, if irritation occurs discontinue use. 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.

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