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| Product NDC Code | 53175-001 | ||||||||
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| Drug Name | Hydrogen peroxide |
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| Type | Generic | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 91349 | ||||||||
| Application Number | M003 | ||||||||
| Labeler Name | Dyad Medical Sourcing, LLC | ||||||||
| Packages |
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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 daily may be covered with a sterile bandage if bandaged, let dry first 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 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
First aid antiseptic:
| Oral debriding agent (oral rinse): adults and children 2 years of age and over:
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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 the 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 HCS NDC 53175-001-16 Solution of Hydrogen Peroxide 3% USP 10 Volume FIRST AID ANTISEPTIC ORAL DEBRIDING AGENT For treatment of minor cuts, scrapes and burns For use as a gargle or rinse For external use only SEALED FOR YOUR PROTECTION IF SEAL IS BROKEN OR MISSING DO NOT USE Manufactured for:Dyad Medical Sourcing, LLC 2101 Waukegan Road, Suite 208 Bannockburn, IL 60015 1-855-241-1773 • [email protected] Made in USA #902-HCS0202 Rev. 02 ©2020 Dyad Medical Sourcing, LLC www.hcsmed.com Reorder No. HCS0202 16 FL OZ (1 PT) 473 mL PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label Back 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.For external use only 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