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 Dolgencorp, 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, mucous 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


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

Oral debriding agent 9oral rinse): adults and children 2 years of age and over:
•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 or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor


Other Information



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


Inactive Ingredient



purified water


Adverse Reactions



Distributed by

Old East Main

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

871.000/871AA


Principal Display Panel



Rexall
Hydrogen Peroxide Topical Solution USP

3% H202

  • For treatment of minor cuts and abrasions
  • First Aid Antiseptic
  • 10 FL OZ (295 mL)

    Hydrogen Peroxide Topical Solution USP

    • First aid antiseptic
    • Oral debriding agent
    • For treatment of minor cuts and abrasions

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

      100% satisfaction guaranteed (888)309-9030

      16 FL OZ (1 PT) 473 mL


* Please review the disclaimer below.