FDA Label for Tribioticlc Lc LC

View Indications, Usage & Precautions

Tribioticlc Lc LC Product Label

The following document was submitted to the FDA by the labeler of this product Hart Health. 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 Ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base)

Polymyxin B Sulfate 5,000 units

Lidocaine 40mg


Otc - Purpose



Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

Topical Anesthetic


Indications & Usage



Uses: First aid to help prevent infection and temporarily relieve pain in
  • minor cuts
  • scrapes
  • burns
  • abrasions

Warnings



Warnings: For external use only

Serious burns require immediate medical attention



Adverse Reactions



Allergy alert: Do not use if you are allergic to any of the ingredients


Otc - Do Not Use



do not use
  • in or near the eyes
  • over large portions of the body
  • in large quantities, particularly over raw surfaces or blistered areas
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily

Otc - Ask Doctor



Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Stop Use



Stop use and ask a doctor if
  • condition worsens or lasts for more than 7 days
  • a rash or other allergic reaction occurs
  • symptoms clear up and occur again within a few days


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.


Dosage & Administration



Directions:

Do not use more than directed.

Adults and children 12 years of age and over:

  • clean the affected area
  • apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • Children under 12 years of age: ask a doctor


Inactive Ingredient



Petrolatum


Package Label.Principal Display Panel



tribioticlc.jpg


* Please review the disclaimer below.