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 Pharmacy Value Alliance Llc. 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


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 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 puncture 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 redness 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 1 to 3 times a day
  • may be covered with sterile bandage
  • if bandaged, let dry first

  • Oral debriding agent:

    adults, children over 2 years of age:

    • mix with equal amount of water
    • swish around in the mouth over the affected area for at least 1 minute, then spit out
    • use up to 4 times daily after meals and at bedtime
    • children uner 12 years of age should be supervused in the use
    • children under 2 years of age: consult a dentist, doctor

Other Information



keep tightly closed and a controlled room temperature.  Do not shake bottle.  Hold away from face when opening.


Inactive Ingredient



purified water


Questions?



1-888-593-0593


Other



DISTRIBUTED BY:

Pharmacy Value Alliance LLC

407 East Lancaster Avenue,

Wayne. PA 19087  www.emersongroup.com


Principal Display Panel



Premier Value

Hydrogen Peroxide topical solution USP

first aid antiseptic

oral debriding agent

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

32 FL OZ (1 QT) 946 mL

871.001/871AA


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