Hydrogen Peroxide Liquid
FDA Label NDC 67326-354

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Degasa Sa De Cv for the product Hydrogen Peroxide (NDC 67326-354). 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 active ingredient, purpose, inactive ingredients:, uses:, warnings:, do not use:, stop use and ask a doctor if, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Purpose

First Aid Antiseptic Oral debriding agent

Inactive Ingredients:

Purified water

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 ocassional sore mouth.

Warnings:

For external use only.

Do Not Use:

  • In the eyes or apply over large areas of the body.
  • Longer than 1 week.

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.

Otc - Ask Doctor

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

Otc - Keep Out Of Reach Of Children

Keep out of reach of Children if swallowed, get medical help or contact a poison control center right away.

Directions

First aid antiseptic:

√ Clean the affected area.

√ Apply a small amount of product on the affected area 1 o 3 times a day

√ May be covered with a sterile bandage.

√ If bandaged, let dry first.

Oral debriding agent:

Adults, children over 2 years of age:

√ 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.

√ Children under 12 years of age should be supervised in the use.

√ Children under 2 years of age: consult a dentist, doctor.

Other Information

√ Keep tightly closed and at controlled room temperature.

√ Do not shake bottle.

√ Hold away form face when opening.

Question Or Comments?

Call 956 728-8899

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