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| Product NDC Code | 53462-075 | ||||||||
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| Drug Name | Perox-a-mint solution |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | BUCCAL | ||||||||
| Dosage Form | MOUTHWASH | ||||||||
| RxCUI drug identifier | 358975, 1866540 |
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| Application Number | M022 | ||||||||
| Labeler Name | Sage Products, 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 Hydrogen Peroxide 1.5%
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 Use up to 4 times daily or as directed by a dentist or doctor. Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate. Children under 12 years of age: supervise use. Children under 3 years of age: consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Blue 1 (CI42090), menthol flavor, phosphoric acid, polysorbate 80, sodium saccharin, Water, Yellow 6 (CI15985)
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 removal of secretions associated with sore mouth
Purpose
Information about the drug product’s indications for use.Purpose Oral Debriding Agent
Spl product data elements
Usually a list of ingredients in a drug product.Perox-A-Mint Solution HYDROGEN PEROXIDE WATER PHOSPHORIC ACID POLYSORBATE 80 SACCHARIN SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 6 HYDROGEN PEROXIDE HYDROGEN PEROXIDE
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.Perox-A-Mint Solution Perox-A-Mint Bottle (44 mL) Perox-A-Mint Burst Pouch (7 mL)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: For more than 7 days unless told to do so by a doctor. Avoid swallowing.
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 debriding 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 doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain or redness persists of worsens.
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 more than 7 days unless told to do so by a doctor. Avoid swallowing. Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain or redness persists of worsens. Keep out of reach of children. If more than used for debriding 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