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TopCare Triple Antibiotic Plus Pain Relief

Medically reviewed on Jan 10, 2018

Dosage form: ointment
Ingredients: Bacitracin zinc 500[iU] in 1g, Neomycin sulfate 3.5mg in 1g, Polymyxin B sulfate 10000[iU] in 1g, Pramoxine hydrochloride 10mg in 1g
Labeler: Topco Associates LLC
NDC Code: 36800-056

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.

TopCare®
Triple Antibiotic Plus Pain Relief

Drug Facts

Active ingredients (each gram contains)Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine hydrochloride 10 mgExternal analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort 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

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

Stop use and ask a doctor if
  • condition persists or gets worse
  • you need to use longer than 1 week
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • 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
  • Adults and children 2 years of age and older:
    • 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
  • Children under 2 years of age: ask a doctor

Other information
  • To open: unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

QUESTIONS?

1-888-423-0139

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

TopCare®

MAXIMUM STRENGTH

Triple Antibiotic Ointment
+ Pain Relief

BACITRACIN ZINC, NEOMYCIN SULFATE
POLYMYXIN B SULFATE AND PRAMOXINE HCL

QUALITY
GUARANTEED

COMPARE TO
NEOSPORIN® + PAIN RELIEF
active ingredients*

NET WT 1 OZ (28.4 g)

TOPCARE   TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-056
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin zinc (Bacitracin) Bacitracin500 [iU]  in 1 g
Neomycin sulfate (Neomycin) Neomycin3.5 mg  in 1 g
Polymyxin B sulfate (Polymyxin B) Polymyxin B10000 [iU]  in 1 g
Pramoxine hydrochloride (Pramoxine) Pramoxine hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:36800-056-241 TUBE in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B03/31/2012
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-056)

 
Topco Associates LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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