Hydrogen Peroxide Liquid
FDA Label NDC 53329-981

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Hydrogen Peroxide (NDC 53329-981). 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, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, 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

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, mucus, or other secretions associated with occasional sore mouth

Warnings

For external use only.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If

  • 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.

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: 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, 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. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.

Inactive Ingredients

purified water

Principal Display Panel - Packet

Medline Hydrogen Peroxide 3% Pdp (C0e8220e 3d9d 437e 9914 7c294988e2ea 01)

Medline Hydrogen Peroxide 3% Pdp (C0e8220e 3d9d 437e 9914 7c294988e2ea 01)

Medline

NDC: 53329-981-06

Hydrogen

Peroxide

3%

First aid antiseptic

Oral debriding agent

Product sealed

For your protection

16 FL OZ

(1 PT) 473 mL

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