Hcs Hydrogen Peroxide 3% Liquid
FDA Label NDC 83506-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Concordance Healthcare Solutions, Llc. for the product Hcs Hydrogen Peroxide 3% (NDC 83506-001). 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, 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

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

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 in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

purified water

Principal Display Panel – 473 Ml Bottle Label

HCS

NDC 83506-001-16

Solution of
Hydrogen Peroxide
3% USP 10 Volume

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

  • For treatment of minor
    cuts, scrapes, and burns
  • For use as a gargle or rinse
  • For external use only

    • SEALED FOR YOUR PROTECTION

    IF THE SEAL IS BROKEN OR MISSING DO NOT USE

    16 FL OZ (1 PT) 473 mL

    Principal Display Panel – 473 mL Bottle Label (Hcs04 0000 01)

    Principal Display Panel – 473 mL Bottle Label (Hcs04 0000 01)

* Please review the disclaimer below.