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| Product NDC Code | 63940-435 | ||||
|---|---|---|---|---|---|
| Drug Name | Anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 313029 | ||||
| Application Number | M021 | ||||
| Labeler Name | Libertu Procurement, Inc | ||||
| Packages |
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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 WATER ALCOHOL HYDROGEN PEROXIDE POLOXAMER 407 SACCHARIN SODIUM SUCRALOSE MENTHOL PHOSPHORIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM 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.principal display panel CORE VALUES Compare to Listerine Healty White Vibrant Advanced WHITENING ANTICAVITY MOUTHRINSE Begins working on contact Safely whitens teeth Kills germs that cause bad breath 5 DAYS to Whiter Teeth Fresh Mint IMPORTANT: Read directions for proper use. 946 mL (32 FL OZ) Sealed With Printed Neckband For Your Protection 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.Other information store at room temperature (59º-77ºF)
Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened. *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Vibrant Anticavity Mouthrinse To open: remove tamper evident neckband. Squeeze both tabs at base of cap while turning the cap until loose. To close: Place cap back on bottle and turn cap until it clicks twice and feels secure Distributed by Liberty Procurement Co. Inc. Union, NJ 07083 USA www.facevalues.com SATISFACTION GUARANTEED Or Your Money Back
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 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