031725ab-4e9a-48c4-86a4-7c6ba1d996e6

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

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


Medication Information

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
Uses

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

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic

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
Description

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

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

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

Inactive Ingredient

White Petrolatum

Questions Or Comments?

Call 1-800-935-6737

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

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
Uses

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

  • cuts
  • scrapes
  • burns
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
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

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

Inactive Ingredient (Inactive ingredient)

White Petrolatum

Questions Or Comments? (Questions or comments?)

Call 1-800-935-6737

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)