ASTONEA FIRST AID- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment 
ASTONEA LABS PRIVATE LIMITED

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ASTONEA Triple Antibiotic

Active ingredients
(in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

Purpose

First Aid AntibioticFirst Aid AntibioticFirst 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 ■ if you are allergic to any of the ingredients ■ over large areas of the body ■ longer than 1 week unless directed by a doctor

Ask a physician before use in case of

■ deep or puncture wounds ■ animal bites ■ serious burns

Stop use and consult a doctor if

■ the 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 ■ 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 room temperature 15-30C (59-86F) ■ avoid excessive heat and humidity■Tamper evident■Do not use if packet is cut, torn or opened

Inactive ingredients

white petrolatum

Package Label

Principal Display and Drug Fact Panel

ASTONEA  FIRST AID
bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  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 B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-302-530.9 g in 1 PACKET; Type 0: Not a Combination Product05/02/2022
2NDC:77338-302-5428.3 g in 1 TUBE; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00405/02/2022
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Registrant - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 6/2024
Document Id: 1bbad68f-2934-5848-e063-6394a90a448d
Set id: de0982e3-37ab-a829-e053-2995a90a53e8
Version: 3
Effective Time: 20240625
 
ASTONEA LABS PRIVATE LIMITED