TOPCARE  TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment 
Topco Associates LLC

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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TopCare®
Triple Antibiotic Plus Pain Relief

Drug Facts

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

Uses

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

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

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • 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

Other information

Inactive ingredient

white petrolatum

Questions?

Call 1-888-423-0139

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

TopCare®
health

NDC 36800-056-24

MAXIMUM STRENGTH

Triple Antibiotic Ointment
+ Pain Relief
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCL
First Aid Antibiotic / Pain Relieving Ointment

• OUR PHARMACISTS
RECOMMEND •

NET WT 1 OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [iU]  in 1 g
Neomycin sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [iU]  in 1 g
Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-056-241 in 1 CARTON03/31/2012
128.4 g in 1 TUBE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-056)

Revised: 4/2019
Document Id: 046e7bf1-e381-42fe-b5f0-47eea7d9edd9
Set id: 0fc0dbc6-ca1d-42be-8016-68e64f119706
Version: 2
Effective Time: 20190405
 
Topco Associates LLC