FDA Label for Quality Choice Maximum Strength Triple Antibiotic

View Indications, Usage & Precautions

Quality Choice Maximum Strength Triple Antibiotic Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc. 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 zinc 500 units......................................................... First aid antibiotic

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

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

Pramoxine hydrochloride 10 mg.............................................. First aid analgesic


Otc - Purpose



Uses

Helps prevent infection and temporarily relieves pains due to:

  • minor cuts
  • scrapes
  • burns

Warnings



Warnings

For external use only

Allergy alert: do not use if allergic to any of the ingredients


Otc - Do Not Use



Do not use

  • in or near the eyes
  • over large areas of the body
  • longer than 1 week

Otc - Ask Doctor



Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns


Otc - Stop Use



Stop use and ask a doctor if:

  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and comes back within a few days
  • a rash or other allergic reaction occurs

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center right away.


Indications & Usage



Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount equal to surface area of a finger tip, on area 1 to 3 times daily
  • may be covered with a sterile bandage
  • Children under 2 years of age: ask a doctor


Storage And Handling



Other information

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

Inactive Ingredient



Inactive ingredients

methylparaben, liquid paraffin, white petrolatum, polyoxyl 40 stearate, proplyparaben


Dosage & Administration



DISTRIBUTED BY:

C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995 USA

Made in Korea


Package Label.Principal Display Panel




* Please review the disclaimer below.