CAREONE  TRIPLE ANTIBIOTIC - bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment 
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (each gram contains)Purpose
Bacitracin zinc 400 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 5,000 unitsFirst aid antibiotic

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week

Ask a doctor before use

  • on deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • condition persists or gets worse
  • 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 controlled room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

DISTRIBUTED BY: American Sales Company
4201 Walden Avenue, Lancaster, NY 14086

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

TRIPLE ANTIBIOTIC OINTMENT

FIRST AID ANTIBIOTIC OINTMENT

0.5 oz
(14.2 g)

Helps Prevent Infection in Minor Cuts, Scrapes, and Burns.

Principal Display Panel - 14.2 g Tube Carton
CAREONE   TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin) Bacitracin400 [iU]  in 1 g
Neomycin Sulfate (Neomycin) Neomycin3.5 mg  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:41520-016-011 in 1 CARTON
114.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B12/14/1995
Labeler - American Sales Company (809183973)
Registrant - Taro Pharmeceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmeceuticals Inc.206263295MANUFACTURE(41520-016)

Revised: 01/2013
Document Id: 128aa1e3-96c7-46a1-a80c-ad6fd55e8ce6
Set id: 3534a7a1-f3cc-467e-b18e-1d37b3acce1f
Version: 1
Effective Time: 20130114
 
American Sales Company