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| Product NDC Code | 55910-163 | ||||
|---|---|---|---|---|---|
| Drug Name | Anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 1038904 | ||||
| Application Number | M021 | ||||
| Labeler Name | Dolgencorp, LLC | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reaction Since 1903 Rexall ® is a registered trademark of Rexall Sundown, Inc. DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 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 DSP-TN-21091 DSP-MO-20087DSP-MO-28 SDS-MO-20068
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride 0.02% w/v (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 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 (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, 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
Spl product data elements
Usually a list of ingredients in a drug product.Anticavity SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER ALCOHOL SORBITOL POLOXAMER 407 EUCALYPTOL METHYL SALICYLATE MENTHOL, UNSPECIFIED FORM PHOSPHORIC ACID SACCHARIN SODIUM THYMOL 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 Anticavity Fluoride Mouthwash Sodium Fluoride and Acidulated Phosphate Topical Solution Helps prevent cavities and restore enamel Kills bad breath germs Eucalyptus mint flavor IMPORTANT: read directions for proper use. 1 L (1 QT 1.8 FL OZ) 33.8 FL OZ image description
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Tamper Evident Statement SEALED WITH PRINTED NACKBAND FOR YOUR PROTECTION
Storage and handling
Information about safe storage and handling of the drug product.Other information store at controlled room temperature 20⁰- 25⁰C (68⁰- 77⁰F) 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.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