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| Product NDC Code | 0135-0234 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Aquafresh extreme clean whitening action |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | DENTAL | ||||||
| Dosage Form | PASTE | ||||||
| RxCUI drug identifier | 1044547 | ||||||
| Application Number | M022 | ||||||
| Labeler Name | Haleon US Holdings LLC | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride (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 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 consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (whitening action) water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, sodium lauryl sulfate, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, synthetic iron oxide, red 30
Inactive ingredients (deep action) water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, iron oxide, red 30
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 WHITENING ACTION sodium fluoride WATER HYDRATED SILICA SORBITOL GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE XANTHAN GUM TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE SACCHARIN SODIUM D&C RED NO. 30 SODIUM FLUORIDE FLUORIDE ION AQUAFRESH EXTREME CLEAN DEEP ACTION sodium fluoride WATER HYDRATED SILICA SORBITOL GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE XANTHAN GUM COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE SACCHARIN SODIUM D&C RED NO. 30 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 NDC 0135-0234-08 Aquafresh ® fluoride toothpaste triple protection ® EXTREME CLEAN ® WITH MICRO-ACTIVE FOAMING ACTION whitening action Sugar Acid Protection** from Fluoride mint blast helps restore natural whiteness TWIN VALUE PACK 2 TUBES OF 5.6 OZ (158.7g) EACH TOTAL NET WT 11.2 OZ (317.4g) Aquafresh ® Extreme Clean ® Whitening Action toothpaste creates micro-active foam which seeks out hard to reach places in your mouth and fights bad breath. It rinses clear and carefully polishes your teeth so after only one tube you’ll be left with significantly cleaner, smoother, whiter teeth*. Take the Feeling of Clean to the Extreme! ® Sugar Acid Protection** **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 *vs a regular toothpaste ALWAYS FOLLOW THE LABEL Trademarks are owned by or licensed to the GSK group of companies. AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies. GSK Consumer Healthcare Warren, NJ 07059 ©2015 GSK group of companies 1-800-897-5623 105517XA C:\Users\jx336321\Pictures\Drug Listing\105517XA_Aquafresh Extreme Clean Whitening Action 0234_2 x 5.6 oz.JPG
Principal Display Panel NDC 0135-0432-02 Aquafresh ® fluoride toothpaste triple protection ® EXTREME CLEAN ® WITH MICRO-ACTIVE FOAMING ACTION + WHITENING deep action Sugar Acid Protection** from Fluoride mint zest for a whole mouth clean NET WT 5.6 oz (158.7g) Aquafresh ® Extreme Clean ® Deep Action toothpaste creates micro-active foam which seeks hard to reach places; in between teeth and even the back of your tongue and rinses clear to leave your teeth clean and smooth. Enjoy a whole mouth clean. 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. healthy gums* strong teeth fresh breath *with twice daily brushing ALWAYS FOLLOW THE LABEL AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies. GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2015 GSK group of companies We value your feedback 1-800-897-5623 101883XD Aquafresh Extreme Clean Deep Action 5.6 oz carton
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 you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.
Keep out of reach of children under 6 years of age. (Whitening Multi Action only) 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 (English/Spanish) weekdays
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 you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Keep out of reach of children under 6 years of age. (Whitening Multi Action only) 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