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| Product NDC Code | 0135-0605 | ||||
|---|---|---|---|---|---|
| Drug Name | Aquafresh sensitive maximum strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 1038929 | ||||
| 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 ingredients Potassium Nitrate (5%)* Sodium fluoride 0.24% (0.15% w/v fluoride ion) *maximum FDA sensitivity active ingredient
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 12 years of age and older: o apply at least a 1-inch strip of the product onto a soft bristle toothbrush. o brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. • children under 12 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, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide, menthol, 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.Uses • aids in the prevention of dental cavities. • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Purpose
Information about the drug product’s indications for use.Purpose Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.AQUAFRESH SENSITIVE MAXIMUM STRENGTH potassium nitrate and sodium fluoride POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA SORBITOL GLYCERIN SODIUM LAURYL SULFATE TITANIUM DIOXIDE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE MENTHOL, UNSPECIFIED FORM D&C RED NO. 30 FD&C BLUE NO. 1 smooth 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 0135-0605-01 Aquafresh ® TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION triple protection ® DENTIST RECOMMENDED ACTIVE INGREDIENTS maximum strength* sensitive Sugar Acid Protection** from Fluoride • healthy gums† • strong teeth • fresh breath smooth mint NET WT 5.6 OZ (158.8 g) Aquafresh ® Maximum Strength* Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy. With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth . **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack. targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity †with twice daily brushing ALWAYS FOLLOW THE LABEL Trademarks are owned by or licensed of the GSK group of companies. GSK Consumer Healthcare Warren, NJ 07059 *maximum FDA sensitivity active ingredient ©2015 GSK or its licensor. 105481XA C:\Users\sh821028\Pictures\105481XA_Aquafresh Sensitive Maximum Strength_5_6oz_cartion.
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. 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
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use.
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. Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children. 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