LUCKY SUPERSOFT FIRST AID- bacitracin neomycin polymyxin b ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
Available from:
Anicare Pharmaceuticals pvt. Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antibiotic First aid antibiotic First aid antibiotic first aid to help prevent infection in minor:  ■ cuts ■ scrapes ■ burns ■ if you are allergic to any of the ingredients ■ in the eyes ■ over large areas of the body ■ deep or puncture wounds ■ serious burns ■ animal bites  ■ you need to use longer than 1 week ■ condition persists or gets worse ■ rash or other allergic reaction develops
Authorization status:
OTC monograph final
Authorization number:
47046-175-01

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LUCKY SUPERSOFT FIRST AID- bacitracin neomycin polymyxin b ointment

Anicare Pharmaceuticals pvt. Ltd.

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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triple Anitibiotic

Active ingredients

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Use

first aid to help prevent infection in minor: ■ cuts ■ scrapes ■ burns

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

■ deep or puncture wounds ■ serious burns ■ animal bites

Stop use and consult 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.

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 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing

or if the tube tip is cut prior to opening

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Package Label

LUCKY SUPERSOFT FIRST AID

bacitracin neomycin polymyxin b ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:470 46 -175

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BACITRACIN (UNII: 58 H6 RWO52I) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

40 0 [USP'U] in 1 g

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN

3.5 mg in 1 g

PO LYMYXIN B SULFATE (UNII: 19 371312D4) (POLYMYXIN B - UNII:J2VZ0 7J9 6 K)

POLYMYXIN B

50 0 0 [USP'U] in 1 g

Anicare Pharmaceuticals pvt. Ltd.

Inactive Ingredients

Ingredient Name

Stre ng th

CO CO A BUTTER (UNII: 512OYT1CRR)

CO TTO NSEED O IL (UNII: H3E8 78 0 20 N)

O LIVE O IL (UNII: 6 UYK2W1W1E)

SO DIUM PYRUVATE (UNII: POD38 AIF0 8 )

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:470 46 -175-0 1

14 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333B

0 1/31/20 15

Labeler -

Anicare Pharmaceuticals pvt. Ltd. (916837425)

Revised: 12/2020

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