Dynarex Hp 3
FDA Label NDC 67777-306

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Dynarex Hp 3 (NDC 67777-306). 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 otc - active ingredient, purpose, warnings, indications & usage, keep out of reach of children, dosage & administration, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                       Purpose

Hydrogen peroxide 3% v/v                         Antiseptic

                                                                   Oral debriding agent

Purpose

First aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns
  • aids in the removal of phlegm, mucus, or other secretions associated with occassional sore mouth.

Warnings

  • For external use only
  • Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.
    • Stop use and ask a doctor if condition persist or gets worse.
    • Sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling rash or fever develops

Indications & Usage

Do not use:

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

Keep Out Of Reach Of Children

Keep out of reach of children.

IIf swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

DIRECTIONS as a  First Aid Antiseptic:

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

    • DIRECTIONS as a Oral Debriding Agent:

    Adults, children over 2 years of age:

    • mix with an equal amount of water
    • swish around the mouth in 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 dentis or doctor

Other Information

  • keep tightly closed and at controlled room temperature.
  • do not shake bottle
  • Hold away from face when opening

Inactive Ingredient

Inactive Ingredient

  • Water

Principal Display Panel

DYNAREX 3% Hydrogen Peroxide

Hydrogen Peroxide.jpg

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