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  5. Label Information: Family Care Triple Antibiotic Plus Pain Relief

FDA Label for Family Care Triple Antibiotic Plus Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INDICATIONS & USAGE
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. DOSAGE & ADMINISTRATION
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Family Care Triple Antibiotic Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. 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)                                                   Purpose

Bacitracin 500 units....................................................................... First aid antibiotic

Neomycin sulfate 3.5 mg................................................................ First aid antibiotic

Polymyxin B sulfate 10,000 units...................................................... First aid antibiotic

Pramoxine hydrochloride 10mg........................................................ First aid antibiotic


Otc - Purpose



Uses

first aid to help prevent infection and for temporarily relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns


Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

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

  • you need to use longer than 1 week
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • the condition persists or gets worse
  • rash or allerfic reaction develops

Otc - Keep Out Of Reach Of Children



Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center immediately


Indications & Usage



Directions

  • adults and children 2 years of age and older:
  • clean the affected area
  • apply a 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 stearile bandage
  • children under 2 years of age: ask a doctor

Storage And Handling



Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients

ethanol, liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum


Dosage & Administration



Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos CA, 90703 USA

Made in Korea


Package Label.Principal Display Panel



image description - 523

image description - 523


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