Triple Antibiotic Maximum Strength: Package Insert and Label Information

TRIPLE ANTIBIOTIC MAXIMUM STRENGTH- bacitracin zinc, neomycin and polymyxin b sulfate ointment
Budpak Inc.

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Active Ingredients
Bacitracin Zinc 400U
Neomycin 3.5mg
Polymyxin B sulfate 5000U
Purpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
Usesfirst aid to help prevent infection in minor cuts scrapes burns Warnings
For external use only
Do not use • in the eyes if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor over large areas of the body Ask a doctor before use on • on deep puncture wounds, animal bites, or serious burns Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions
Clean the affected area and dry thoroughly
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 Other information
Store at 68 to 77F (20C-25C) See carton or tube crimp for lot number and expiration date Inactive ingredients Petrolatum, Mineral oil, Ozocerite, Propanediol, Methylparaben, Propylparaben Package Label
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image of package label
TRIPLE ANTIBIOTIC MAXIMUM STRENGTH
bacitracin zinc neomycin polymyxin b sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:27293-014
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN ) BACITRACIN ZINC 400 [USP’U] in 1 g
NEOMYCIN (NEOMYCIN ) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B ) POLYMYXIN B SULFATE 5000 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
PROPANEDIOL
METHYLPARABEN
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27293-014-01 1 TUBE (TUBE) in 1 BOX contains a TUBE (27293-014-14)
1 NDC:27293-014-14 14 g in 1 TUBE This package is contained within the BOX (27293-014-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 08/19/2011
Labeler — Budpak Inc. (183224849)
Establishment
Name Address ID/FEI Operations
Nantong Zhongbao Pharmaceutical Co., Ltd 420795668 manufacture

Revised: 08/2011 Budpak Inc.

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