SPL v3
SPL
SPL Set ID 031725ab-4e9a-48c4-86a4-7c6ba1d996e6
Route
TOPICAL
Published
Effective Date 2024-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (5 mg) Polymyxin B (10000 [USP'U]) Pramoxine (10 mg)
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin) Polymyxin B Sulfate 10000 units Pramoxine Hydrochloride 10 mg

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic


Medication Information

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic

Description

Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin) Polymyxin B Sulfate 10000 units Pramoxine Hydrochloride 10 mg

Uses

first aid to help prevent infection and for the temporary relief of pain in minor:

  • cuts
  • scrapes
  • burns
Section 50565-1

 Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purposes

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Warnings
  • For External Use Only

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few day
  • a rash or other allergic reaction develops
Directions

Adults and children 2 years of age and older

  • clean 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

Children under 2 years of age:ask a doctor

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 20° to 25°C (68° to 77°F)
  • avoid excessive heat and humidity
  • see crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredient

White Petrolatum

Questions Or Comments?

Call 1-800-935-6737

Principal Display Panel

NDC 37835-904-01

Triple Antibiotic Ointment + Pain Relief

First Aid Antibiotic/Pain Relieving Ointment

Compare to the Active Ingredients in Neosporin ® + Pain Relief *

*This product is not manufactured or distributed by Johnson & Johnson Corporation Products Company, Inc, owner of the registered trademark Neosporin ®+ Pain Relief .

Net. Wt. 1 oz (28.4 g)

Distributed by:

Bi-Mart

Eugene, OR 97402

Active Ingredients (in Each Gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate 10000 units

Pramoxine Hydrochloride 10 mg


Structured Label Content

Uses

first aid to help prevent infection and for the temporary relief of pain in minor:

  • cuts
  • scrapes
  • burns
Section 50565-1 (50565-1)

 Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purposes

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Warnings
  • For External Use Only

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few day
  • a rash or other allergic reaction develops
Directions

Adults and children 2 years of age and older

  • clean 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

Children under 2 years of age:ask a doctor

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 20° to 25°C (68° to 77°F)
  • avoid excessive heat and humidity
  • see crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredient (Inactive ingredient)

White Petrolatum

Questions Or Comments? (Questions or comments?)

Call 1-800-935-6737

Principal Display Panel

NDC 37835-904-01

Triple Antibiotic Ointment + Pain Relief

First Aid Antibiotic/Pain Relieving Ointment

Compare to the Active Ingredients in Neosporin ® + Pain Relief *

*This product is not manufactured or distributed by Johnson & Johnson Corporation Products Company, Inc, owner of the registered trademark Neosporin ®+ Pain Relief .

Net. Wt. 1 oz (28.4 g)

Distributed by:

Bi-Mart

Eugene, OR 97402

Active Ingredients (in Each Gram) (Active Ingredients (in each gram))

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate 10000 units

Pramoxine Hydrochloride 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)