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| Product NDC Code | 53943-514 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Mouthwash |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1043619 | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | DISCOUNT DRUG MART | ||||||||
| 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 Eucalyptol 0.092% Menthol 0.042% Methyl Salicylate 0.060% Thymol 0.064%
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 rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night. Do not swallow.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingreduebts Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.
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.Uses to help reduce and prevent plaque and gingivitis.
Purpose
Information about the drug product’s indications for use.Purpose Antiplaque/Antigingivitis
Spl product data elements
Usually a list of ingredients in a drug product.Mouthwash Eucalyptol, Menthol, Methyl Salicylate, Thymol CARAMEL ALCOHOL POLOXAMER 407 WATER BENZOIC ACID SODIUM BENZOATE METHYL SALICYLATE SALICYLIC ACID MENTHOL MENTHOL THYMOL THYMOL EUCALYPTOL EUCALYPTOL
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.Package Principal Display Panel Mouth wash
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 (1-800-222-1222).
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at room temperature. cold weather may cloud this product. Its antiseptic properties are not affected.
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 Do not use for children under 12 years of age. 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 (1-800-222-1222).
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