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Crest plus cavity protection cool mint gel - Medication Information

Product NDC Code 69423-816
Drug Name

Crest plus cavity protection cool mint gel

Type Brand
Active Ingredients
Sodium fluoride 1.5 mg/g
Route DENTAL
Dosage Form GEL, DENTIFRICE
RxCUI drug identifier 891775
Application Number M021
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
69423-816-57 1 tube in 1 carton (69423-816-57) / 161 g in 1 tube
69423-816-82 1 tube in 1 carton (69423-816-82) / 232 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, trisodium phosphate, cellulose gum, flavor, sodium phosphate, sodium saccharin, carbomer, 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 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.
Crest Plus Cavity Protection Cool Mint Gel Sodium Fluoride SACCHARIN SODIUM SODIUM PHOSPHATE, TRIBASIC SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE SODIUM PHOSPHATE FD&C BLUE NO. 1 CARBOXYMETHYLCELLULOSE SODIUM SODIUM FLUORIDE FLUORIDE ION CARBOXYPOLYMETHYLENE

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 - 161 g Carton ADA ACCEPTED American Dental Association Crest Plus FLUORIDE ANTICAVITY TOOTHPASTE NET WT 5.7 OZ (161 g) CAVITY PROTECTION WITH ACTIVE FLUORIDE Cool Mint Gel Label

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 Dist. by Procter & Gamble, Cincinnati OH 45202 www.crest.com

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. 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? 1-800-492-7378

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