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| Product NDC Code | 0363-0163 | ||||
|---|---|---|---|---|---|
| Drug Name | Mouth rinse |
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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 | Walgreen | ||||
| 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 Ingredients Sodium fluoride 0.0221% (0.01% 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 under 12 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 anything for 30 minutes after rinsing •supervise children as necessary until capable of using without supervision •children under 12 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.Mouth Rinse sodium fluoride WATER ALCOHOL SORBITOL POLOXAMER 407 SODIUM LAURYL SULFATE EUCALYPTOL METHYL SALICYLATE MENTHOL PHOSPHORIC ACID SACCHARIN SODIUM THYMOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SUCRALOSE FD&C RED NO. 40 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 Walgreens WALGREENS-PHARMACIST RECOMMENDED Compare to the active ingrediebt in Listerine Total Care Anticavity Mouthwash Anticavity Rinse SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION Restores Enamel Freshens Breath Helps prevent cavities Strengthen teeth Kills bad breath germs Eucalyptus Mint flavor 33.8 fl oz (1 L) IMPORTANT: Read directions for proper use 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.Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands. This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, owner of the registered trademark Listerine DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD, DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED 2021 Walgreen Co. MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS
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 1-800-925-4733
Storage and handling
Information about safe storage and handling of the drug product.Other information •store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ 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.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