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Act restoring anticavity fluoride cool mint - Medication Information

Product NDC Code 41167-0957
Drug Name

Act restoring anticavity fluoride cool mint

Type Brand
Active Ingredients
Sodium fluoride .2 mg/ml
Route TOPICAL
Dosage Form MOUTHWASH
RxCUI drug identifier 240698,
656809
Application Number M021
Labeler Name Chattem, Inc.
Packages
Package NDC Code Description
41167-0957-5 532 ml in 1 bottle, plastic (41167-0957-5)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Sodium fluoride 0.05% (0.02% 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 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1 (245-167) www.actfluoride.com

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.
ACT Restoring Anticavity Fluoride Cool Mint sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER ALCOHOL SORBITOL POLOXAMER 407 PROPYLENE GLYCOL SODIUM BENZOATE SODIUM PHOSPHATE POLYSORBATE 20 SACCHARIN SODIUM CETYLPYRIDINIUM CHLORIDE EDETATE CALCIUM DISODIUM ANHYDROUS FD&C BLUE NO. 1 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

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 #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORI NG ANTICAVITY FLUORIDE MOUTHWASH COOL MINT 18 fl oz (532 mL) #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL MINT 18 fl oz (532 mL)

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 Other information do not use if safety seal is broken or missing

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 rinsing 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 If more than used for rinsing 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