FDA Label for Dynarex Hp 3

View Indications, Usage & Precautions

Dynarex Hp 3 Product Label

The following document was submitted to the FDA by the labeler of this product Dynarex Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.