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 Healthwell. 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.

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Drug Facts


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

Otc - When Using



For external use only


Otc - Do Not Use



Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week

Otc - Ask Doctor



Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns


Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



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 area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
  • Oral debriding agent (oral 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 in a cool dark place. Do not shake bottle. Hold away from face when opening.


Inactive Ingredient



Purified Water


Principal Display Panel - 946 Ml Bottle Label



Tamper evident cap for your protection

if ring-band is broken or missing, do not use.

Part # HSN2239

NDC #87010-001-32

HYDROGEN PEROXIDE

3% USP 10 VOLUME

3%

FIRST AID ANTISEPTIC
Made in USA

32 FL. OZ. (946 mL)


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