DOUBLE ANTIBIOTIC- bacitracin zinc 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), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
Available from:
Rugby Laboratories, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antibiotic First aid to help prevent infection in - minor cuts - scrapes - burns
Authorization status:
OTC monograph final
Authorization number:
0536-1174-20, 0536-1174-28

DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment

Rugby Laboratories, Inc.

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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Poly Antibiotic Ointment - Bacitracin Zinc, Polymyxin B Sulfate

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc, USP 500 units

Polymyxin B sulfate, USP 10,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

minor cuts

scrapes

burns

Warnings

For external use only

Allergy alert:

do not use if allergic to any of the ingredients

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

When using this product

do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

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 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 15° to 25°C (59° to 77°F).

Before using any medication, read all label directions. Keep carton, it contains important

information.

Inactive ingredient

white petrolatum

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.

Principal Display Panel

Rugby

Compare to the active ingredients in Polysporin

NDC 0536-1174-20

Double Antibiotic Ointment

(Bacitracin Zinc and Polymyxin B Sulfate Ointment, USP)

First Aid Antibiotic

First Aid to Help Prevent Infection in Minor Cuts, Scrapes, and Burns

Net wt. 0.5 oz (14g)

Protection Against Infection

For Minor Cuts, Scrapes, and Burns

DOUBLE ANTIBIOTIC

bacitracin zinc and polymyxin b sulfate ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 536 -1174

Rugby Laboratories, Inc.

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

50 0 [USP'U] in 1 g

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

POLYMYXIN B

10 0 0 0 [USP'U] in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 536 -1174-20

1 in 1 CARTON

0 3/20 /20 19

1

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

2

NDC:0 536 -1174-28

1 in 1 CARTON

0 3/25/20 19

2

28 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 MONOGRAPH FINAL

pa rt333B

0 3/20 /20 19

Labeler -

Rugby Laboratories, Inc. (079246066)

Revised: 11/2019

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