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| Product NDC Code | 43128-001 | ||||||
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| 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 | NDC, Inc. | ||||||
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Hydrogen Peroxide (stabilized) 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 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 age & 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
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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 first aid to help prevent the risk of infection in minor cuts, scrapes and burns aids in removal of phlegm, mucous, 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 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 - 473 mL Bottle Label REF: P903016 NDC 43128-001-16 Hydrogen Peroxide 3% USP Tamper evident cap for your protection. If ring-band is detached from cap or missing do not use. 16 oz. ( 473 mL ) Made in USA for: NDC, Inc., 407 New Sanford Rd. La Vergne, TN 37086 www.ProAdvantagebyNDC.com Pro ADVANTAGE ® by NDC Principal Display Panel
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 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 body longer than 1 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 in a cool dark place 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 1 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 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 Keep out of reach of children. If 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