Hydrogen Peroxide
FDA Label NDC 52862-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Home Smart Products for the product Hydrogen Peroxide (NDC 52862-007). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (by volume)

Hydrogen Peroxide 3%

Otc - Purpose

Purpose

first aid antiseptic/oral debriding agent

Indications & Usage

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 occasional sore mouth

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • in the eyes or apply over large areas of the body
  • longer than one week
  • on deep or puncture wounds, animal bites or on serious burns

Otc - Ask Doctor

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

Otc - Stop Use

Stop use and ask a doctor if

  • the condition persists or gets worse
  • swelling, rash or fever develops
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children.

If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Dosage & Administration

Directions

first aid antiseptic:

  • clean the affected area
  • apply small amount of product on the affected area 1-3 times a day
  • may be covered with a sterile bandage
  • if bandaged, let dry first

    • oral debriding agent:

    • adults and children 2 years of age and over:
    • mix with 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

Other information

  • Keep bottle tightly closed and in a dark place at a controlled room temperature.
  • Do not shake bottle.
  • Hold away from face when opening.

    • PRINCIPAL DISPLAY PANEL

    HEALTH SMART HYDROGEN PEROXIDE LIQUID
    FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

    16 FL.OZ (473 mL)

Inactive Ingredient

Inactive ingredients

Water

Package Label.Principal Display Panel

Hydrogen-peroxide (Hydrogen Peroxide)

Hydrogen-peroxide (Hydrogen Peroxide)

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