Bacitracin Zinc Ointment Usp

Bacitracin Zinc Ointment Usp
SPL v3
SPL
SPL Set ID d914abe1-5e14-5673-e053-2a95a90ac91b
Route
TOPICAL
Published
Effective Date 2022-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U])
Inactive Ingredients
Mineral Oil Paraffin White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-04

Description

Bacitracin Zinc (500 units in each gram)

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc (500 units in each gram)

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only

1oz Label

1oz Carton

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.

Do Not Use
  • In the eyes or apply over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor
Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited

Plot No. A327, T.T.C Indl. Area, M.I.D.C

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 02/2022

0.5oz Label

0.5oz Carton

Active Ingredient

Bacitracin Zinc (500 units in each gram)

Other Information
  • Do not use if seal on the tube is damaged or is not visible
  • To open,unscrew cap, pull tab to remove foil seal
  • Store at room temperature
  • Avoid excessive heat and humidity
  • Preserve in well-closed container
  • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

Stop Use and Ask A Doctor If

the condition persists or gets worse

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.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns


Structured Label Content

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns

Purpose

First Aid Antibiotic

Warnings

For external use only

1oz Label

1oz Carton

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.

Do Not Use (Do not use)
  • In the eyes or apply over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor
Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited

Plot No. A327, T.T.C Indl. Area, M.I.D.C

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 02/2022

0.5oz Label

0.5oz Carton

Active Ingredient

Bacitracin Zinc (500 units in each gram)

Other Information
  • Do not use if seal on the tube is damaged or is not visible
  • To open,unscrew cap, pull tab to remove foil seal
  • Store at room temperature
  • Avoid excessive heat and humidity
  • Preserve in well-closed container
  • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

the condition persists or gets worse

if 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites, or serious burns


Advanced Ingredient Data


Raw Label Data

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