Hydrogen Peroxide Solution
FDA Label NDC 83324-176

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Hydrogen Peroxide (NDC 83324-176). 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, 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 rise 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 then 1 week

Ask A Doctor Before Use If

you have deep or puncture 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
  • apply a small amount of product on the affected area 1 to 3 times a day
  • 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

      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

Adverse Reaction

Distributed by C D M A., Inc

43157 W 9 Mile Rd, Novi, MI 48375

www.qualitychoice.com Questions: 800-935-2362

Principal Display Panel

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

QC

QUALITY

CHOICE

Hydrogen

Peroxide

Topical

Solution

First Aid Antiseptic/

Oral Debriding Agent

For Treatment of Minor

Cuts and Abrasions

For Use as a Gargle or Rinse

32 FL OZ (946 mL)

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Image Description (Mm1)

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