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| Product NDC Code | 0135-0590 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Aquafresh cavity protection |
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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 (Cavity Protection, Extra Fresh +Whitening, Multi Action Whitening) Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Active ingredient ( ultimate white) Sodium fluoride 0.24% (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 of age: Consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (Cavity Protection) water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1
Inactive ingredients (Extra Fresh +Whitening) water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1
Inactive ingredients (Multi Action Whitening) water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, red 30, blue 1
Inactive ingredients (ultimate white) water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium saccharin, 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 CAVITY PROTECTION sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA SORBITOL GLYCERIN SODIUM LAURYL SULFATE XANTHAN GUM TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM CARRAGEENAN D&C RED NO. 30 FD&C BLUE NO. 1 cool mint AQUAFRESH EXTRA FRESH PLUS WHITENING sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA SORBITOL GLYCERIN SODIUM LAURYL SULFATE XANTHAN GUM TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM CARRAGEENAN D&C RED NO. 30 FD&C BLUE NO. 1 fresh mint AQUAFRESH MULTI ACTION WHITENING sodium fluoride SODIUM FLUORIDE FLUORIDE ION 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 D&C RED NO. 30 FD&C BLUE NO. 1 AQUAFRESH ultimate white sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA SORBITOL GLYCERIN SODIUM TRIPOLYPHOSPHATE ANHYDROUS POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE TITANIUM DIOXIDE XANTHAN GUM SODIUM HYDROXIDE SACCHARIN SODIUM D&C RED NO. 30 FD&C BLUE NO. 1
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 0135-0590-01 Aquafresh ® fluoride toothpaste triple protection ® • healthy gums* • strong teeth • fresh breath cavity protection Sugar Acid Protection** from Fluoride cool mint NET WT 5.6 OZ (158.8 g) **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack. *with twice daily brushing 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 Made in Taiwan 1-800-897-5623 105263XA Aquafresh Cavity Protection 5.6oz (158.8g) carton
Principal Display Panel NDC 0135-0591-01 Aquafresh ® fluoride toothpaste triple protection ® • healthy gums* • strong teeth • fresh breath extra fresh +whitening Sugar Acid Protection** from Fluoride fresh mint NET WT 5.6 OZ (158.8 g) **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack. *with twice daily brushing 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 105282XA Aquafresh Extra Fresh plus Whitening 5.6oz (158.8g) carton
Principal Display Panel NDC 0135-0594-01 Aquafresh ® fluoride toothpaste triple protection ® WHITENING MULTI ACTION Sugar Acid Protection** from Fluoride NET WT 5.6 OZ (158.8 g) cavity protection healthy gums* breath great taste whitening† enamel Invigorating Mint cavity protection healthy gums* fresh breath great taste removes surface stains enamel strengthening **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shidl that protects the tooth surface against sugar acid attack. *with twice daily brushing †whitens by removing surface stains 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 105384XA Aquafresh Multi Action Whitening 5.0 oz (158.8g) carton
Principal Display Panel NDC 0135-0592-01 Aquafresh ® fluoride toothpaste triple protection ® ultimate white Sugar Acid Protection** from Fluoride with whitening action frost mint NET WT6.0 OZ (170.1 g) Aquafresh ® Ultimate White toothpaste gently polishes your teeth, lifts away stains and helps to prevent new stains appearing. **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attach. • healthy gums† • strong teeth • fresh breath †with twice daily brushing 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 105287XA Aquafresh ultimate white 6.0 oz (170.1 g) 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 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