TRIPLE ANTIBIOTIC PLUS PAIN RELIEF - bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment 
Kareway Product, Inc.

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 (in each gram)

Bacitracin Zinc 500 units
Neomycin 3.5mg
Polymyxin B Sulfate 10,000 units
Pramoxine HCl 10mg

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 HCI 10 mgExternal analgesic

Uses

First aid to help prevent infection and provide 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

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
  • condition persists 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

Other information

store at 20°-25°C (68°-77°F)

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment + Pain Relief
Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic Ointment

Maximum Strengthimage of carton label

NET WT 1 oz (28.3 g)


Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Inactive ingredients

white petrolatum

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:67510-0670
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES) Bacitracin Zinc500 [iU]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate10000 [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:67510-0670-31 in 1 CARTON
19.4 g in 1 TUBE
2NDC:67510-0670-11 in 1 CARTON
228.3 g in 1 TUBE
3NDC:67510-0670-51 in 1 CARTON
314 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/12/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 9/2011
Document Id: 969a2577-ac11-4818-a76d-eb0dc7323612
Set id: 395e9db3-dea8-4ba6-b88a-8a7851c5ad90
Version: 2
Effective Time: 20110928
 
Kareway Product, Inc.