FIRST AID TRIPLE ANTIBIOTIC AND PAIN RELIEF MAXIMUM STRENGTH- bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrocloride ointment

First Aid Triple Antibiotic and Pain Relief by

Drug Labeling and Warnings

First Aid Triple Antibiotic and Pain Relief by is a Otc medication manufactured, distributed, or labeled by LIFElabs, a Division of Atico International USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

First Aid Triple Antibiotic and Pain Relief (Maximum Strength)

Active Ingredients

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

PURPOSE

Purposes

• First aid antibiotic
• Pain reliever

WARNINGS

Warnings

For external use only

Allergy alert:

• do not use if allergic to any of the ingredients
  

DO NOT USE

Do not use

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

ASK DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns
  

STOP USE

Stop use and ask a doctor if

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

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

Adults and children 2 years and older:

• clean affected area
• may be covered with a sterile bandage
• apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily.
  

Children under 2 years: ask a doctor

STORAGE AND HANDLING

Other information

store at 59o - 86oF (15o - 30oC)

INACTIVE INGREDIENT

Inactive Ingredients

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

QUESTIONS

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

INDICATIONS & USAGE

Uses

• First aid to help prevent infection in minor cuts, scrapes, and burns
• First aid for the temporary relief of pain in minor cuts, scrapes, and burns
  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID TRIPLE ANTIBIOTIC AND PAIN RELIEF  MAXIMUM STRENGTH
bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrocloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51852-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin Zinc	500 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin Sulfate	3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B Sulfate	10000 [USP'U]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Mineral Oil (UNII: T5L8T28FGP)
Methylparaben (UNII: A2I8C7HI9T)
Polyoxyl 40 Stearate (UNII: 13A4J4NH9I)
Propylparaben (UNII: Z8IX2SC1OH)
Petrolatum (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51852-100-01	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	11/01/2010

Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)