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Product NDC Code | 63645-179 | ||||
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Drug Name | Cph anti-bacterial breath mist |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
Application Number | part356 | ||||
Labeler Name | OraLabs | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Cetylpyridinium chloride 0.09%
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 12 years of age and older: Spray 3 times in the oral cavity. Children 6-12 years of age: Supervise use. Children under 6 years: Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citric Acid, Flavor, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Potassium Sorbate, Sodium Benzoate, Sucralose, Water.
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 Helps fight odor causing bacteria
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial
Spl product data elements
Usually a list of ingredients in a drug product.CPH Anti-bacterial Breath Mist Cetylpyridinium chloride WATER CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM HYDROGENATED CASTOR OIL MENTHOL, (+)- SUCRALOSE
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/Label Principal Display Panel CPH Anti-bacterial Spray
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 swallowed get medical help or contact a Poison Control Center right away.
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 For external use only: Do not use this product if gums are irritated or bleeding unless directed to do by a doctor or dentist. If more than twice the recommended amount for tongue spraying is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not spray into the eyes. Do not spray into the eyes. If spray gets into the eyes, hold eyelids apart and flush the eye continuously with running water for at least 15 minutes.
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