TRIPLE ANTIBIOTIC EXTRA STRENGTH- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, Inc., Anicare Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Drug Facts

Bacitracin zinc 400 Units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 Units

Purpose

First aid antibiotic

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

First aid to help prevent infection in minor

• cuts
• scrapes
• burns
  

Warnings

For external use only

Allergy Alert: do not use if you are allergic to any of the ingredients

Do not use

• in or near  eyes
• on large areas of the body
• Consult a doctor before use if you have
  

Directions

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

Other information

• store at controlled room temperature between 68° - 77° F  (20° - 25° C)

Inactive ingredients

methylparaben, mineral oil, ozocerite, petrolatum, propanediol, propylparaben

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Extra Strength

Triple Antibiotic Ointment

First Aid Antibiotic Ointment

Protection against infection

First aid treatment for minor cuts, scrapes and burns

• Bacitracin zinc
• Neomycin sulfate
• Polymyxin-B sulfate
  

NET WT. 0.33 OZ.  (9.4 g)

Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 48084 U.S.A.

Code No. MH/DRUGS/KD-313               Made in India

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC  EXTRA STRENGTH
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-2436
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 9.4 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 9.4 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 9.4 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-2436-1	9.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	07/10/2013

Labeler - Personal Care Products, Inc. (966155082)

Registrant - Personal Care Products, Inc. (966155082)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd.		916837425	manufacture(29500-2436)