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Arc enamel protection - Medication Information

Product NDC Code 69423-785
Drug Name

Arc enamel protection

Type Brand
Active Ingredients
Sodium fluoride 1.5 mg/g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 891775
Application Number M021
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
69423-785-40 1 tube in 1 carton (69423-785-40) / 113 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 0.243% (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 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 yrs.: ask a dentist

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients sorbitol, water, hydrated silica, sodium lauryl sulfate, cellulose gum, flavor, sodium phosphate, trisodium phosphate, sodium saccharin, carbomer, sodium benzoate, red 40

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 helps protect against cavities

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
ARC Enamel Protection Sodium Fluoride SACCHARIN SODIUM SORBITOL WATER HYDRATED SILICA SODIUM PHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SODIUM FLUORIDE FLUORIDE ION SODIUM BENZOATE FD&C RED NO. 40 CARBOXYPOLYMETHYLENE SODIUM LAURYL SULFATE

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 - 113 g Tube Carton ARC ENAMEL PROTECTION FLUORIDE TOOTHPASTE HAPPY HOUR STRAWBERRY DAIQUIRI NET WT 4.0 OZ (113 g) 69423-785

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts DISTR.BY PROCTER & GAMBLE CINCINNATI, OH 45202 2022 P&G

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 yrs. of age.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-866-989-3951

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.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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 Keep out of reach of children under 6 yrs. 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