Hydrogen Peroxide Solution
FDA Label NDC 68599-2301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Medical-surgical Inc. for the product Hydrogen Peroxide (NDC 68599-2301). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Distributed By McKesson Medical-Surgical Inc.
Richmond, VA 23228

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

Otc - Do Not Use

  • Do not use
    • in the eyes or apply over large areas of the body
    • longer than 1 week

Otc - Ask Doctor

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

Otc - Stop Use

  • 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 - 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 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 and at controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

purified water

Principal Display Panel - 473 Ml Bottle Label

NDC 68599-2301-6

McKESSON

Hydrogen
Peroxide 3%

TOPICAL SOLUTION USP
FIRST AID ANTISEPTIC
ORAL DEBRIDING AGENT

For treatment of minor cuts and abrasions.
For use as a gargle or rinse.

16
FL OZ (1 pt)
(473 mL)

TAMPER EVIDENT CAP FOR YOUR
PROTECTION. IF RING-BAND
IS DETACHED FROM CAP OR
MISSING DO NOT USE.

MFR # 23-D0012

Distributed By McKesson Medical-Surgical Inc.
Richmond, VA 23228
LU-5750-1112    1-07-D0012R10    Rev. 2
Made in USA

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