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  5. Label Information: Hcs Hydrogen Peroxide 3%

FDA Label for Hcs Hydrogen Peroxide 3%

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT
    12. PRINCIPAL DISPLAY PANEL – 473 ML BOTTLE LABEL

Hcs Hydrogen Peroxide 3% Product Label

The following document was submitted to the FDA by the labeler of this product Concordance Healthcare Solutions, 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


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 – 473 Ml Bottle Label



HCS

NDC 83506-001-16

Solution of
Hydrogen Peroxide
3% USP 10 Volume

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

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