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| Product NDC Code | 10733-800 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrogen peroxide |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL, TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| Application Number | M003 | ||||
| Labeler Name | MEDICAL PRODUCTS LABORATORIES, INC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Hydrogen Peroxide 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 For use as a first aid antiseptic: clean affected area apply small amount of product on affected area 1-3 times a day may be covered with a sterile bandage if bandaged, let dry first For use as an oral debriding agent (oral rinse): adults and children 2 years of age and over: mix with an equal amount of water swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow. use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years 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 associated 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 HYDROGEN PEROXIDE HYDROGEN PEROXIDE WATER
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.TOPICAL SOLUTION FIRST AID ANTISEPTIC ORAL DEBRIDING AGENT For treatment of minor cuts & abrasions For use as a gargle or rinse Questions or comments? Call 1-800-523-0191
10733-800-16 front lable back label
10733-800-08 Package Label Package Label
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information keep tightly closed and in a dark place at room temperature. do not shake bottle. Hold 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 . Do not use: in the eyes or apply over large areas of the body longer than one week Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns Stop use and ask a doctor if swelling, rash, or fever develops the condition persists or gets worse sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens
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