BACITRACIN ZINC ointment

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

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Active ingredient:
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
Available from:
Anicare Pharmaceuticals Pvt. Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antibiotic First aid to help prevent infection in - scrapes   - minor cuts - burns -  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 - you need to use longer than 1 week - condition persists or gets worse - symptoms persists for more than 1 week or clear up and occur again within a few days  - a rash or other allergic reaction develops
Authorization status:
OTC monograph final
Authorization number:
47046-155-01, 47046-155-02

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BACITRACIN ZINC- bacitracin zinc 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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Bacitracin Zinc Ointment

Active Ingredient

Bacitracin Zinc 500 units

Purpos e

First aid antibiotic

USES

First aid to help prevent infection in

scrapes

minor cuts

burns

WARNINGS

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

Before using, consult a doctor if you have

deep or puncture wounds

animal bites

serious burns

STOP USE and ask a doctor if

you need to use longer than 1 week

condition persists or gets worse

symptoms persists for more than 1 week or clear up and occur again within a few days

a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

If swallowed get medical help or contact a Poison Control Center immediately.

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 room temperature 15° to 25°C (59° to 77°F).

Before using any medication, read all label directions.

Keep carton, it contains important information.

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

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

PRINCIPAL DISPLAY PANEL

Bacitracin Zinc Ointment

NET WT 0.5 OZ (14g)

BACITRACIN ZINC

bacitracin zinc ointment

Anicare Pharmaceuticals Pvt. Ltd

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:470 46 -155

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

Inactive Ingredients

Ingredient Name

Stre ng th

PARAFFIN (UNII: I9 O0 E3H2ZE)

MINERAL O IL (UNII: T5L8 T28 FGP)

WHITE PETRO LATUM (UNII: B6 E5W8 RQJ4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:470 46 -155-0 2

1 in 1 CARTON

12/0 9 /20 20

1

NDC:470 46 -155-0 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 -155)

Revised: 12/2020

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