Berkley Jensen
FDA Label NDC 76772-028

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi for the product Berkley Jensen (NDC 76772-028). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, warnings, otc - keep out of reach of children, stop use, ask doctor, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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