3% Hydrogen Peroxide
FDA Label NDC 79590-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mbs Medical Technologies, Inc. for the product 3% Hydrogen Peroxide (NDC 79590-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, warnings, otc - keep out of reach of children, dosage & administration, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Hydrogen peroxide 3%
Purpose
first aid antiseptic / oral debriding agent
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.
Dosage & Administration
Directions For use as a first aid antiseptic: *Clean affected area. *if bandaged, let dry first. *apply small amount of product on affected area 1-3 times a day. *may be covered with a sterile bandage. 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.
Other Information
*Keep tightly closed and in a dark place at room temperature.
*Do not shake bottle. Hold away from face when opening.
Inactive Ingredient
Inactive ingredient purified water
Other
Antiseptic
* For treatment of minor cuts and abrasions.
* Oral debriding agent.
* Use as a gargle or rinse.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Packaging
3% H2o2 (3 H2o2 Label)
* Please review the disclaimer below.
