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Anticavity - Medication Information

Product NDC Code 55301-435
Drug Name

Anticavity

Type Brand
Active Ingredients
Sodium fluoride .1 mg/ml
Route ORAL
Dosage Form MOUTHWASH
RxCUI drug identifier 313029
Application Number part355
Labeler Name Your Military Exchanges
Packages
Package NDC Code Description
55301-435-43 473 ml in 1 bottle, plastic (55301-435-43)
55301-435-45 946 ml in 1 bottle, plastic (55301-435-45)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Sodium fluoride 0.02% (0.01% w/v fluoride ion) Purpose Anticavity

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 twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) 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 (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, 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.
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.
Anticavity Sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER ALCOHOL HYDROGEN PEROXIDE POLOXAMER 407 SACCHARIN SODIUM SUCRALOSE MENTHOL PHOSPHORIC ACID 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 Exchange Select Compare to Listerine HealthyWhite Vibrant Anticavity Mouthrinse* WHITENING MOUTHRINSE ANTICAVITY 5 days to whiter teeth Helps strengthen teeth Kills germs that cause bad breath quality value 16 FL OZ (1 PT) 473 mL image description

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.
SEALED WITH PRINTED NECK BAND FOR YOUR PROTECTION *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Vibrant Anticavity Mouthrinse Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightl or release air when opened. "Satisfaction guaranteed or your money back." Manufactured for your Military Exchanges By Vi-Jon, 8515 Oage Avenue St. Louis, MO 63114

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature (59º-77ºF)

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 For this product

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