ASTONEATRIPLE ANTIBIOTIC PAIN RELIEF- bacitracin,neomycin,polymxin, pramoxine ointment 
ASTONEA LABS PRIVATE LIMITED

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Astonea Triple Antibiotic Pain relief Ointment

DRUG FACTS

Active Ingredient

Bacitracin zinc 500 Units

Neomycin sulfate (3.5mg)

Polymyxin B sulfate (10000 units)

Pramoxine HCI (10mg)

Purpose

First Aid Antibiotic

external analgesic

Uses

First Aid to help prevent infection and for temporary relief of pain in minor:

Warnings

For external use only.

Do not use

If you are allergic to any of the ingredients
In eyes
Over large areas of the body

Ask a Doctor before Use

Ask Doctor before use if you have:

  • Deep or puncture wouns
  • Animal bites
  • Serious burns

When using this product

use only as directed

Stop Use and ask a Doctor if:

  • You need to use longer than 1 week
  • Condition persists or gets worse
  • 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 (1-800-222-1222).

Directions

Other Information

Inactive Ingredient:

White Petrolatum

Packaging

Principal Display and Drug Fact Panel

ASTONEATRIPLE ANTIBIOTIC PAIN RELIEF 
bacitracin,neomycin,polymxin, pramoxine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-229
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-229-011 in 1 BOX05/01/2023
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00405/01/2023
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 12/2023
Document Id: 0d8128c5-9bfb-c706-e063-6294a90a1aa0
Set id: 0d81120b-f39e-bcde-e063-6294a90a70b7
Version: 1
Effective Time: 20231227
 
ASTONEA LABS PRIVATE LIMITED