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Cvs pharmacy restore and defend - Medication Information

Product NDC Code 69842-251
Drug Name

Cvs pharmacy restore and defend

Type Brand
Active Ingredients
Stannous fluoride .15 g/100g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 416784
Application Number M021
Labeler Name CVS Pharmacy
Packages
Package NDC Code Description
69842-251-19 1 tube in 1 carton (69842-251-19) / 96.4 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Stannous Fluoride (0.454% w/w)

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: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth Do not swallow 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, glycerin, hydrated silica, sodium tripolyphosphate, sodium saccharin, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium lauryl sulfate, flavor

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 builds increasing protection against painful sensitivity of the teeth aids in the prevention of dental cavities

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
CVS Pharmacy Restore and Defend Fluoride SACCHARIN SODIUM GLYCERIN WATER SODIUM TRIPOLYPHOSPHATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM LAURYL SULFATE STANNOUS 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.
Carton label

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 accidently swallowed, get medical help or contact a Poison Control Center right away.

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

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 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 Keep out of reach of children. If more than used for brushing is accidently 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