Bacitracin

Bacitracin
SPL v3
SPL
SPL Set ID 253e5b98-c64f-3226-e063-6294a90a9352
Route
TOPICAL
Published
Effective Date 2024-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-24

Description

Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

Purpose

Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

Dosage and Administration

Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for 2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails


Medication Information

Purpose

Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

Dosage and Administration

Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by

a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting,

ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for

2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails

Description

Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

Uses

Uses

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

Section 51945-4

Warnings

For External Use Only

Direction

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 over large areas of the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a

doctor.

Ask A Doctor

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Active Ingridient

Active Ingredient (in each gram) Purpose

Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

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 Preserve in well-closed containers, preferably at controlled room temperature.

Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

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.

Active Ingredient (in Each Gram) Purpose

Active Ingredient (in each gram) Purpose

Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic


Structured Label Content

Uses (USES)

Uses

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

Section 51945-4 (51945-4)

Warnings (WARNINGS)

For External Use Only

Direction (DIRECTION)

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)

Do not use In the eyes or over large areas of the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a

doctor.

Ask A Doctor (ASK A DOCTOR)

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Active Ingridient (ACTIVE INGRIDIENT)

Active Ingredient (in each gram) Purpose

Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

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 Preserve in well-closed containers, preferably at controlled room temperature.

Inactive Ingredients (INACTIVE INGREDIENTS)

Mineral Oil, Paraffin, White Petrolatum

Dosage and Administration (dosage and administration)

Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by

a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting,

ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for

2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails

Keep Out of Reach of Children (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.

Active Ingredient (in Each Gram) Purpose (Active Ingredient (in each gram) Purpose)

Active Ingredient (in each gram) Purpose

Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic


Advanced Ingredient Data


Raw Label Data

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