ASTONEA FIRST AID- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

Astonea by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

ASTONEA  FIRST AID
bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [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: 77338-302-53	0.9 g in 1 PACKET; Type 0: Not a Combination Product	05/02/2022
2	NDC: 77338-302-54	28.3 g in 1 TUBE; Type 0: Not a Combination Product	05/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	05/02/2022

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Registrant - ASTONEA LABS PRIVATE LIMITED (878533295)