TRIPLE ANTIBIOTIC PLUS- polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl ointment

Triple Antibiotic Plus by

Drug Labeling and Warnings

Triple Antibiotic Plus by is a Otc medication manufactured, distributed, or labeled by G&W Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (in each gram)

Bacitracin zinc 500 units
Neomycin 3.5 mg
Polymyxin B sulfate 10,000 units
Pramoxine hydrochloride 10.0 mg

PURPOSE

First Aid Antibiotic
Topical analgesic

USES

first aid to help prevent infection and provide temporary relief of pain or discomfort in minor cuts scrapes burns

WARNINGS

For external use only.
Do not use
if you are allergic to any of the ingredients
in the eyes
  over large areas of the body
longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have
deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if
the condition persists or gets worse
a rash or other allergic reaction develops
symptoms persist for more than 1 week, or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

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 sterile bandage
children under 2 years of age: consult a doctor

OTHER INFORMATION

store at room temperature

INACTIVE INGREDIENT

light mineral oil, white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

G&W
Triple Antibiotic Plus Ointment
Polymyxin B Sulfate Bacitracin Zinc Neomycin Sulfate Pramoxine HCl
First Aid Antibiotic / Pain Relieving Ointment
NET WT. 1 oz (28.4g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC PLUS  
polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0713-0622
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Light Mineral Oil (UNII: N6K5787QVP)
Petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0713-0622-31	28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	02/28/1998

Labeler - G&W Laboratories, Inc. (001271188)

Registrant - G&W Laboratories, Inc. (001271188)

Establishment
Name	Address	ID/FEI	Business Operations
G&W Laboratories, Inc.		001271188	MANUFACTURE