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| Product NDC Code | 53462-275 | ||||
|---|---|---|---|---|---|
| Drug Name | Antiplaque solution |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | BUCCAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 1251617 | ||||
| Application Number | M022 | ||||
| Labeler Name | Sage Products LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient ANTIPLAQUE: Cetylpyridinium chloride .05%
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 Before opening, turn package over, burst solution packet with thumbs. Peel lid to open. Remove Mouth Moisturizer and Applicator Swab. Attach Toothbrush to suction line. Clean teeth and oral cavity for approximately one minute. To suction, place thumb over port. To clear tubing, rinse with sterile saline or appropriate solution. Discard Toothbrush. Reattach Covered Yankauer to suction line. Place Mouth Moisturizer on Applicator Swab. Apply as needed to lips and inside mouth. Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution. Children ages 6 to 12 years: supervise use. Children under 6 years of age: do not use. Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands. Ensure foam is intact after use. If not, remove any particles from oral cavity.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C 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.Uses Aids in the removal and prevention of plaque that leads to gingivitis.
Purpose
Information about the drug product’s indications for use.Purpose Antigingivitis/antiplaque
Spl product data elements
Usually a list of ingredients in a drug product.Antiplaque solution CETYLPYRIDINIUM CHLORIDE WATER SORBITOL PEPPERMINT POTASSIUM SORBATE FD&C BLUE NO. 1 POLYSORBATE 80 POLYSORBATE 20 CITRIC ACID MONOHYDRATE CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM
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.Antiplaque Solution Packet
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 under 6 year of age. If more than used for brushing 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 toll-free 800-323-2220
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a dentist if: Gingivitis, bleeding or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
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 Stop use and ask a dentist if: Gingivitis, bleeding or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 year of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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