FDA Label for Hydrogen Peroxide

View Indications, Usage & Precautions

Hydrogen Peroxide Product Label

The following document was submitted to the FDA by the labeler of this product Degasa, S.a. De C.v.. 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.

Active Ingredient



Hydrogen Peroxide (stabilized) 3 %


Purpose



First Aid Antiseptic Oral debriding agent


Inactive Ingredients:



Purified water


Uses:



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 ocassional sore mouth.


Warnings:



For extenal use only.


Do Not Use:



  • In the eyes or apply over large areas of the body.
  • Longer than 1 week.

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.

Ask A Doctor Before Use If



you have deep or puncture wounds, animal bites or serious burns.


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:

    • 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.
    • Children under 12 years of age should be supervised in the use.
    • Children under 2 years of age: consult a dentist, doctor.

Other Information



  • Keep tightly closed and at controlled room temperature.
  • Do not shake bottle.
  • Hold away form face when opening.

Question Or Comments?



Call 956 728-8899


Package Labeling:




* Please review the disclaimer below.