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| Product NDC Code | 76162-576 | ||||
|---|---|---|---|---|---|
| Drug Name | Oral antivavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| Application Number | M021 | ||||
| Labeler Name | Topco | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.active ingredient Sodium fluoride 0.0219% (0.01% 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 twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse bwtween your teeth for 1 minute 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 witout 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, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, 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 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.Oral Antivavity Sodium fluoride WATER GLYCERIN CETYLPYRIDINIUM CHLORIDE SACCHARIN SODIUM PHOSPHORIC ACID SODIUM BENZOATE SUCRALOSE POLOXAMER 407 BENZOIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PROPYLENE GLYCOL FD&C BLUE NO. 1 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 COMPARE TO CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE MOUTHWASH TopCare everyday ALOHOL FREE Fluoride Anticavity Mouthwash REFRESHING MINT Helps strengthen enamel Helps prevent cavities Cleans teeth** Kills bad breath germs Freshens breath Helps keep mouth feeling clean IMPORTANT: Read directions for proper use. 33.8 FL OZ (1 QT 1.8 FL OZ) 1 L 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.claims SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION TopCare everyday Helps strengthen enamel Helps prevent cavities Kills bad breath germs Freshen Breath
DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLATE, IL 60007 ©TOPCO VIJA0122 QUESTIONS? 1-888-423-0139 This rinse may cause temporary staining to the surface of teeth. This is not harmful, add adequate brushing may prevent its occurence This product is not manufactured or distributed by Procter & Gamble, distributof of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash This product is not intended to replace brushing or flossing
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-423-0139
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
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