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 Cariba International. 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


Use



  • 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 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

Ask A Doctor Before Use If You Have



deep or pucture 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 redess 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 coverd with a sterile bandage
  • if bandaged, let dry first
  • Oral debriding agent: adults, children over 2 years of age:

    • mix with an equal amount of water
    • swish around in the mouth over the affected area for at least 1 minure, 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 from face when opening.


Inactive Ingredients



purified water


Other



Distributed by: Cariba International

P.O. Box 1208

Safety Harbor, Florida 34695

MADE IN USA WITH US AND FOREIGN COMPONENTS


Principal Display Panel



CARIBA

HYDROGEN PEROXIDE TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC, ORAL DEBRIDING AGENT

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

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

16 FL OZ (1 PT) 473 mL

871.001/871AA


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