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  5. Label Information: Berkley Jensen Antiseptic

FDA Label for Berkley Jensen Antiseptic

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. STOP USE
    7. ASK DOCTOR
    8. DO NOT USE
    9. DOSAGE & ADMINISTRATION
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT
    12. PACKAGING

Berkley Jensen Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi. 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.

Drug Facts




Active Ingredient



Hydrogen peroxide 3%


Purpose



first aid antiseptic / oral debriding agent


Warnings



For external use only.

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

Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.


Stop Use



Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.


Ask Doctor



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


Do Not Use



Do not use *in the eyes or apply over large areas of the body. *longer than one week.


Dosage & Administration



Directions For use as a first aid antiseptic:

  • Clean affected area.
  •  apply small amount of product on affected area 1-3 times a day.
  • may be covered with a sterile bandage. 
  • For use as an 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 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 dentist or doctor.

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


Packaging



2 - 2

2 - 2


* Please review the disclaimer below.