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| Product NDC Code | 63824-790 | ||||
|---|---|---|---|---|---|
| Drug Name | Cepacol antibacterial |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1251617, 1251619 |
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| Application Number | part356 | ||||
| Labeler Name | RB Health (US) LLC | ||||
| 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 ingredient Cetylpyridinium chloride 0.05%
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 adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients purified water, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5
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 prevent and reduce plaque that leads to: gingivitis, an early form of gum disease bleeding gums
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.Cepacol Antibacterial Cetylpyridinium chloride Cetylpyridinium chloride Cetylpyridinium WATER ALCOHOL GLYCERIN SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM EUCALYPTUS OIL POLYSORBATE 80 METHYL SALICYLATE CINNAMON OIL PEPPERMINT OIL SACCHARIN SODIUM SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS MENTHOL, UNSPECIFIED FORM EDETATE DISODIUM FD&C YELLOW NO. 5
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 - 710 mL Bottle Label NDC 63824-790-80 Cēpacol ® ANTIBACTERIAL* MULTI-PROTECTION MOUTHWASH CPC–Antigingivitis/Antiplaque Oral Rinse *Kills Germs That Cause Bad Breath Reduces Plaque Freshens Breath #1 BRAND IN HOSPITALS TO OPEN: Squeeze both raised finger pads on cap and continue to squeeze while turning. TO CLOSE: Turn cap until it locks completely. 24 FL. OZ. (710 mL) 0336220 062111 PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label
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.Drug Facts
Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224
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 the reach of children under 6 years of age. 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? 1-888-963-3382 You may also report side effects to this phone number.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information this rinse is not intended to replace brushing or flossing store at room temperature 20-25°C (68-77°F) protect from humidity
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 the reach of children under 6 years of age. If more than used for rinsing 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