Hydrogen Peroxide Solution
FDA Label NDC 57243-871

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Salado Sales Inc. for the product Hydrogen Peroxide (NDC 57243-871). 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, use, 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

Use

  • 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

Do Not Use

  • in the eyes or apply over large areas of the body
  • longer than 1 week

Ask A Doctor Before Use If You Have

deep or pucture wounds, animal bites or serious burns

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

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

    • Oral Debriding Agent: 

    • adults, children over 2 years of age
    • mix with 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 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

Other

Distributed By

Salado Sales, Inc.

Temple, TX 76503

saladosales.com

Principal Display Panel

Do not use if printed seal under cap is broken or missing

CVP

HYDROGEN PEROXIDE

TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

ORAL WOUND CLEANSER

Square bottle uses less plastic than a similarly sized round bottle

Recycle (if available in your area)

16 FL OZ (1 PT) 473 mL

Image Description (Mm1)

Image Description (Mm1)

871.001/871AA

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