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  5. Label Information: Hydrogen Peroxide

FDA Label for Hydrogen Peroxide

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTHER
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrogen Peroxide Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center 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.

Otc - Active Ingredient



Active Ingredient

Hydrogen Peroxide 3%


Otc - Purpose



Purpose

first aid antiseptic/oral debriding agent


Indications & Usage



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



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 one week

Otc - Ask Doctor



Ask a doctor before use if you have deep 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 (1-800-222-1222) right away.


Dosage & Administration



Directions

For use a first aid antiseptic:

  • clean affected area
  • apply small amount of product on the affected area 1-3 times a day
  • may be covered with a sterile bandage
  • if bandaged, let dry first

    • For use as an oral debriding agent (oral rinse):

    • adults and children 2 years of age and over:
    • mix with equal amount of water
    • swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow
    • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
    • children under 12 years should be supervised in the use of this product
    • children under 2 years of age: consult a doctor or dentist

Other



Other information

  • Keep tightly closed and in a dark place at room temperature.
  • Do not shake bottle.
  • Hold away from face when opening.

Inactive Ingredient



Inactive Ingredient

Purified Water


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

HYDROGEN PEROXIDE LIQUID
FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

16 FL.OZ (473 mL)


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