SPL v3
SPL
SPL Set ID 5fb447d6-dbbf-6745-e053-2a91aa0ae0bf
Route
TOPICAL
Published
Effective Date 2018-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (3.5 mg) Polymyxin B (5000 [USP'U]) Pramoxine (10 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-06
Description

Bacitracin zinc 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units Pramoxine hydrochloride 10 mg

Purpose

first aid antibiotic External Analgesic

Medication Information

Purpose
  • first aid antibiotic
  • External Analgesic
Description

Bacitracin zinc 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units Pramoxine hydrochloride 10 mg

Uses

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Section 50566-9

Stop use and ask a doctor if

• the condition persists or gets worse

• a rash or other allergic reaction develops

Section 50569-3

Ask a doctor before use if you have

• deep or puncture wounds

• animal bites

• serious burns

Section 51945-4

Net Weight 0.33 oz (9.4g0

NDC#70648-121-01

Warnings

For external use only

Questions

www.ohiolabpharma.us

Directions

• clean the 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

Do Not Use

Do not use

• if you are allergic to any of the ingredients

• in the eyes

• over large areas of the body

• longer than 1 week unless directed by a doctor

Other Information

Store at room temperature

Active Ingredients

Bacitracin zinc 400 units

Neomycin 3.5 mg

Polymyxin B sulfate 5,000 units

Pramoxine hydrochloride 10 mg

Inactive Ingredient

Petrolatum

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses (USES)

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• the condition persists or gets worse

• a rash or other allergic reaction develops

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• deep or puncture wounds

• animal bites

• serious burns

Section 51945-4 (51945-4)

Net Weight 0.33 oz (9.4g0

NDC#70648-121-01

Purpose
  • first aid antibiotic
  • External Analgesic
Warnings

For external use only

Questions

www.ohiolabpharma.us

Directions

• clean the 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

Do Not Use (Do not use)

Do not use

• if you are allergic to any of the ingredients

• in the eyes

• over large areas of the body

• longer than 1 week unless directed by a doctor

Other Information (Other information)

Store at room temperature

Active Ingredients (Active ingredients)

Bacitracin zinc 400 units

Neomycin 3.5 mg

Polymyxin B sulfate 5,000 units

Pramoxine hydrochloride 10 mg

Inactive Ingredient (Inactive ingredient)

Petrolatum

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:41.019231 · Updated: 2026-03-14T22:55:19.604592