Florona Actilife Hydrogen Peroxide 3 % Liquid
FDA Label NDC 85891-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sparrow Life Care Private Limited for the product Florona Actilife Hydrogen Peroxide 3 % (NDC 85891-006). 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 active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrogen peroxide 3%

Purpose

First Aid Antiseptic

Uses

First aid to help prevent the risk of infection in
• Minor cuts
• Scrapes
• Burns
• Aids in the removal of phlegm, Mucus, or other secretions associated with occasional sore mouth.

Warnings

  • For external use only
  • Do not use
  • in the eyes or apply over large area of the body Longer 1 week
  • Ask doctor before use if you have deep or puncture wounds, animal bites or serious burns.
  • Stop use and ask a doctor if the condition persist or gets worse
  • Sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persist or worsen
  • swelling, rash or Fever develops
  • Keep out of reach of children :If swallowed ,get medical help or contact a Poison Control Center right away .
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 year of age : consult a dentist or doctor.

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 bandage, 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 atleast 1 minute and then spit out.
  • Use up to 4 times daily after meals and after bedtime or as direacted by a dentist or doctor

Other Information

  • Keep bottle tightly closed and controlled room temperature.
  • Do not shake bottle. Hold away from face when opening.

Inactive Ingredients

Water

Product Label

Image Description (Image 006)

Image Description (Image 006)

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