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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 Home Smart Products. 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 (by volume)

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
  • on deep or puncture wounds, animal bites or on serious burns

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
  • swelling, rash or fever develops
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of reach of children.

If swallowed, seek professional assistance or contact a Poison Control Center immediately.


Dosage & Administration



Directions

first aid antiseptic:

  • clean the 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

    • oral debriding agent:

    • adults and children 2 years of age and over:
    • mix with 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



Other information

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

    • PRINCIPAL DISPLAY PANEL

    HEALTH SMART HYDROGEN PEROXIDE LIQUID
    FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

    16 FL.OZ (473 mL)


Inactive Ingredient



Inactive ingredients

Water


Package Label.Principal Display Panel



hydrogen-peroxide - hydrogen peroxide

hydrogen-peroxide - hydrogen peroxide


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