TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin and polymyxin b sulfate ointment

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

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Active ingredient:
BACITRACIN ZINC (UNII: 89Y4M234ES) (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:
Purpose First Aid Antibiotic Uses first aid to help prevent infection in - minor cuts - scrapes - burns Do not use - in the eyes - if you are allergic to any of the ingredients - longer than 1 week unless directed by a doctor - over large areas of the body Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops
Authorization status:
OTC monograph final
Authorization number:
47046-154-01, 47046-154-02

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TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin and polymyxin b

sulfate 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 Antibiotic First Aid Antibiotic Ointment

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

Purpose

First 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

longer than 1 week unless directed by a doctor

over large areas of the body

Ask a doctor before use on

on deep puncture wounds, animal bites, or serious burns

Stop use and consult a doctor if the condition persists or gets worse, or if 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 and dry thoroughly

May be covered with a sterile bandage

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

Other Information

Store at 20°C to 25°C (68°F to 77°C)

Lot No. & Exp. Date: see crimp of tube

Inactive Ingredients

cocoa butter, cotton seed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum, hard parrafin,

mineral oil

PRINCIPAL DISPLAY PANEL

Triple Antibiotic First Aid Antibiotic Ointment

NET WT 0.5 OZ (14 g)

TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC

bacitracin zinc, neomycin and polymyxin b sulfate ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:470 46 -154

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (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

Inactive Ingredients

Ingredient Name

Stre ng th

Anicare Pharmaceuticals Pvt. Ltd

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 ACETATE (UNII: 9 E8 X8 0 D2L0 )

WHITE PETRO LATUM (UNII: B6 E5W8 RQJ4)

PARAFFIN (UNII: I9 O0 E3H2ZE)

MINERAL O IL (UNII: T5L8 T28 FGP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:470 46 -154-0 2

1 in 1 BOX

12/0 9 /20 20

1

NDC:470 46 -154-0 1

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

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

12/0 9 /20 20

Labeler -

Anicare Pharmaceuticals Pvt. Ltd (916837425)

Registrant -

Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Anicare Pharmaceuticals Pvt. Ltd

9 16 8 37425

ma nufa c ture (470 46 -154)

Revised: 12/2020

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