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 Mckesson Medical-surgical Inc.. 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

Distributed By McKesson Medical-Surgical Inc.
Richmond, VA 23228


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

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


Inactive Ingredient



purified water


Principal Display Panel - 473 Ml Bottle Label



NDC 68599-2301-6

McKESSON

Hydrogen
Peroxide 3%

TOPICAL SOLUTION USP
FIRST AID ANTISEPTIC
ORAL DEBRIDING AGENT

For treatment of minor cuts and abrasions.
For use as a gargle or rinse.

16
FL OZ (1 pt)
(473 mL)

TAMPER EVIDENT CAP FOR YOUR
PROTECTION. IF RING-BAND
IS DETACHED FROM CAP OR
MISSING DO NOT USE.

MFR # 23-D0012

Distributed By McKesson Medical-Surgical Inc.
Richmond, VA 23228
LU-5750-1112    1-07-D0012R10    Rev. 2
Made in USA


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