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| Product NDC Code | 55910-971 | ||||
|---|---|---|---|---|---|
| Drug Name | Anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| Application Number | part355 | ||||
| Labeler Name | OLD EAST MAIN CO. | ||||
| 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)
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 between your teeth for 1 miute 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, sorbitol, propylene glycol, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, 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 rinse
Spl product data elements
Usually a list of ingredients in a drug product.Anticavity Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION water SORBITOL PROPYLENE GLYCOL SODIUM LAURYL SULFATE POLOXAMER 407 SODIUM BENZOATE PHOSPHORIC ACID SACCHARIN SODIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SUCRALOSE FD&C RED NO. 40 FD&C BLUE NO. 1
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 panel display Since 1903 Rexall Fluoride Anti-Cavity Mouthwash Sodium Fluoride and Acidulated Phosphate Topical Solution Alcohol-Free 6 BENEFITS Freshens breath Restores enamel Helps strengthen teeth to fight cavities Kills bad breath germs Burn free Cleans the entire mouth IMPORTANT: read directions for proper use. FRESH MINT 1 L (33.8 FL OZ) 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.Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc. This product isnot intended to replace brushing or flossing 100% Satisfaction Guaranteed If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied. (888)309-9030 DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072
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 immediately
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature 20 ⁰ - 25 ⁰ C (68 ⁰ - 77 ⁰ F) cold weather may temporarily cloud this product
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.Warning 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