bacitracin_ointment

bacitracin_ointment
SPL v5
SPL
SPL Set ID b4d8ef06-6269-68f7-e053-2995a90ac8ea
Route
topical
Published
Effective Date 2020-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (500 [iU])
Inactive Ingredients
mineral oil paraffin white petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-11-24

Purpose

First Aid Antibiotic

Description

Bacitracin (500 Units in each gram)


Medication Information

Warnings

For external use only

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

First Aid Antibiotic

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
  • 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
  • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

Description

Bacitracin (500 Units in each gram)

Principal Display Panel

Bacitracin sachet and carton 0.9g

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 09/2021

Section 51945-4

Bacitracin tube and carton 14.2g

Do Not Use

  • in the eyes or apply over large areas of body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Active Ingredient

Bacitracin (500 Units in each gram)







Stop Use and Ask 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 Centre right away.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns


Structured Label Content

Warnings

For external use only

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

First Aid Antibiotic

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 (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
  • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

Principal Display Panel

Bacitracin sachet and carton 0.9g

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 09/2021

Section 51945-4 (51945-4)

Bacitracin tube and carton 14.2g

Do Not Use (Do not use)

  • in the eyes or apply over large areas of body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Active Ingredient (Active ingredient)

Bacitracin (500 Units in each gram)







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

the condition persists or gets worse, or 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 Centre 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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