SPL v6
SPL
SPL Set ID 1982b664-e8fd-4030-aa89-f7543e1b487b
Route
TOPICAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Neomycin (3.5 mg) Polymyxin B (10000 [USP'U]) Pramoxine (10 mg)
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-02
Description

Bacitracin Zinc 500 units Neomycin Sulfate 3.5 mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg

Medication Information

Description

Bacitracin Zinc 500 units Neomycin Sulfate 3.5 mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg

Uses

First aid to help prevent infection and for temporary relief of pain in minor: cuts, scrapes and burns

Section 51945-4

Section 55105-1

First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5 mg, & Polymyxin B Sulfate 10,000 units)

External Analgesic (Pramoxine HCl 10mg)

Warnings

Warnings

For external use only

Do not use:

  • In the eyes
  • If you are allergic to any of the ingredients
  • Over large areas of the body

Ask a doctor before use if you have:

  • Animal bites
  • Serious Burns
  • Deep or puncture wounds

Stop use and ask a doctor if:

  • Condition worsens or symptoms persists for more than 7 days or clears up and occurs again within a few days
  • Rash or other allergic reaction develops
Directions

Adults and children 2 years of age and older:

  • Clean the affected area
  • Apply a small amount of this product (an amount equal to the surface 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: do not use, ask a doctor

Inactive Ingredients

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 immediately

Active Ingredients (in Each Gram)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Structured Label Content

Uses

First aid to help prevent infection and for temporary relief of pain in minor: cuts, scrapes and burns

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5 mg, & Polymyxin B Sulfate 10,000 units)

External Analgesic (Pramoxine HCl 10mg)

Warnings

Warnings

For external use only

Do not use:

  • In the eyes
  • If you are allergic to any of the ingredients
  • Over large areas of the body

Ask a doctor before use if you have:

  • Animal bites
  • Serious Burns
  • Deep or puncture wounds

Stop use and ask a doctor if:

  • Condition worsens or symptoms persists for more than 7 days or clears up and occurs again within a few days
  • Rash or other allergic reaction develops
Directions

Adults and children 2 years of age and older:

  • Clean the affected area
  • Apply a small amount of this product (an amount equal to the surface 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: do not use, ask a doctor

Inactive Ingredients

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 immediately

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

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:23.086471 · Updated: 2026-03-14T23:10:46.361818