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| Product NDC Code | 33992-0871 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrogen peroxide |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 91349 | ||||
| Application Number | M003 | ||||
| Labeler Name | Greenbrier International, Inc | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reactions DISTRIBUTED BY Greenbrier International, Inc 500 Volvo Parkway Chesapeake, VA 23320
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrogen peroxide (stablized) 3%
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 First aid antiseptic: clean the affected area apply a small amount of product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first Oral Debriding agent (oral rinse): adults and children 2 years of ago or over: mix with an equal amount of water swish around in the mouth over the affected area for at least 1 minute and then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients purified 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 first aid to help prevent the risk of infection in minor cuts, scrapes and burns aids in the removal of phlegm, mucus, or other secretions assoicated with occasional sore mouth.
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antiseptic Oral debriding agent
Spl product data elements
Usually a list of ingredients in a drug product.Hydrogen Peroxide HYDROGEN PEROXIDE WATER 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.Principal display panel Do not use if printed seal under cap is broken or missing ASSURED Hydrogen Peroxide TOPICAL SOLUTION USP FIRST AID ANTISEPTIC ORAL DEBRIDING AGENT Square bottle uses less plastic then a similarly sized round bottle Recyclable (if available in your area) 32 FL OZ (1QT) 946 mL mm01
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns
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 in the eyes or apply over large areas of the the body longer than one week
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.
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 the condition persists or gets worse sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash or fever develops
Storage and handling
Information about safe storage and handling of the drug product.Other information keep tightly closed and at controlled room temperature. Do not shake bottle. Hold sprayer tip away from face when opening.
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
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