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| Product NDC Code | 46122-334 | ||||
|---|---|---|---|---|---|
| Drug Name | Gnp hydrogen peroxide 3 percent |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 91349 | ||||
| Application Number | M003 | ||||
| Labeler Name | Amerisource Bergen | ||||
| 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 antiseptic use: Clean the affected area, apply a small amount on the area 1 to 3 times daily. For oral rinse use: Adults and children 2 years and older mix with an equal amount of water and swish around and over the affected area then spit out. Use up to 4 times daily or as directed by a dentist or a doctor. Children under 2 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient 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 As an antiseptic to help prevent infection in minor cuts, scrapes, burns. As an oral rinse for temporary use in cleaning of minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.GNP Hydrogen Peroxide 3 Percent 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 NDC 46122-334 -43 Hydrogen Peroxide Solution 3 % USP First Aid Antiseptic 16 fl oz (1 pt) 473 mL Principal Display Panel NDC 46122-334-43 Hydrogen Peroxide Solution 3% USP First Aid Antiseptic 16 fl oz (1 pt) 473 mL
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
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, serious burns.
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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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 at controlled room temperature 15-30C (59-86F). Do not shake.
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 consult a dentist or doctor if: condition persists or gets worse, sore mouth symptoms do not improve in 7 days, irritation, pain, redness or fever develop.
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 except when used as an oral rinse. Do not use in the eyes. Do not apply over large areas of the body. Do not use longer than 1 week unless directed by a dentist or doctor.
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