ASTONEATRIPLE ANTIBIOTIC PAIN RELIEF- bacitracin,neomycin,polymxin, pramoxine ointment

AstoneaTriple Antibiotic Pain Relief by

Drug Labeling and Warnings

AstoneaTriple Antibiotic Pain Relief by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Cuts
• Scrapes
• Burns

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

• adults or children 2 years of age and older:
• 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
• Children under 2 years of age: ask doctor

Other Information

• Store at 20° to 25°C (68° to 77°F)
• do not use if tube seal under cap is broken

Inactive Ingredient:

White Petrolatum

Packaging

INGREDIENTS AND APPEARANCE

ASTONEATRIPLE ANTIBIOTIC PAIN RELIEF 
bacitracin,neomycin,polymxin, pramoxine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-229
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-229-01	1 in 1 BOX	05/01/2023
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	05/01/2023

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)