Hydrogen Peroxide Solution
FDA Label NDC 67751-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Hydrogen Peroxide (NDC 67751-001). 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, uses, warnings, do not use, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Hydrogen Peroxide (stabilized 3%)

Purpose

First aid antiseptic/Oral debriding agent

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

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

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

Other Information

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

purified water

Package Label.Principal Display Panel

Handy Solutions

Hydrogen Peroxide

3% USP Topical Solution

first aid antiseptic 

oral debriding agent

Image Description (Navajoperoxide)

Image Description (Navajoperoxide)

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