Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 418ea251-2d15-4711-bea8-53f3fa1c1a1b
Route
TOPICAL
Published
Effective Date 2022-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-03-18

Description

Bacitracin zinc (500 units bacitracin)

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin zinc (500 units bacitracin)

Uses:

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

Section 50565-1

Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center directly.

Warnings:

For external use only.

Directions:
  • clean affected area
  • apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
  • may cover with a sterile bandage
Do Not Use:
  • in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if allergic to any of the ingredients
Inactive Ingredients:

mineral oil, petrolatum

Questions Or Comments?

1-800-456-7077

Stop Use, Ask A Doctor If:
  • condition persists or gets worse
  • a rash or allergic reaction develops
Active Ingredient (in Each Gram)

Bacitracin zinc (500 units bacitracin)

Principal Display Panel 0.9g Box Label

NDC 70082-601-02

dealmed

Bacitracin

Ointment

First Aid to help prevent

infection in minor cuts,

scrapes and burns

144

Packets

NET WT. 0.9g

PER PACKET

Principal Display Panel 0.9g Pouch Label

dealmed

Bacitracin

Ointment

0.9g (1/32 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com


Structured Label Content

Uses:

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

Section 50565-1 (50565-1)

Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center directly.

Purpose

First Aid Antibiotic

Warnings:

For external use only.

Directions:
  • clean affected area
  • apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
  • may cover with a sterile bandage
Do Not Use:
  • in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if allergic to any of the ingredients
Inactive Ingredients: (Inactive ingredients:)

mineral oil, petrolatum

Questions Or Comments? (Questions or Comments?)

1-800-456-7077

Stop Use, Ask A Doctor If: (Stop use, ask a doctor if:)
  • condition persists or gets worse
  • a rash or allergic reaction develops
Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Bacitracin zinc (500 units bacitracin)

Principal Display Panel 0.9g Box Label (Principal Display Panel - 0.9g Box Label)

NDC 70082-601-02

dealmed

Bacitracin

Ointment

First Aid to help prevent

infection in minor cuts,

scrapes and burns

144

Packets

NET WT. 0.9g

PER PACKET

Principal Display Panel 0.9g Pouch Label (Principal Display Panel - 0.9g Pouch Label)

dealmed

Bacitracin

Ointment

0.9g (1/32 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)