61010-5601, Single Antibiotic With Bacitracin

61010-5601, Single Antibiotic With Bacitracin
SPL v5
SPL
SPL Set ID 4ae9a105-e3f9-4015-8844-085e0b34cdb6
Route
TOPICAL
Published
Effective Date 2016-02-02
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 DRUG Active Since 2008-11-13

Description

Drug Facts

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Drug Facts

Uses:

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

Section 42229-5

Drug Facts

Section 50565-1

For external use only. Keep out of reach of children.

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

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 Box Label

NDC 61010-5601-2

Safetec

First Aid

Single Antibiotic Ointment

• with Bacitracin

• First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder No. 53310

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel Pouch Label

Safetec

Single Antibiotic

Ointment

(Bacitracin)

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077


Structured Label Content

Uses:

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

For external use only. Keep out of reach of children.

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

Purpose

First Aid Antibiotic

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 Box Label (Principal Display Panel - Box Label)

NDC 61010-5601-2

Safetec

First Aid

Single Antibiotic Ointment

• with Bacitracin

• First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder No. 53310

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

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

Safetec

Single Antibiotic

Ointment

(Bacitracin)

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077


Advanced Ingredient Data


Raw Label Data

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