SPL v1
SPL
SPL Set ID 4928d9dd-542b-fe8b-e063-6294a90a9252
Route
TOPICAL
Published
Effective Date 2021-11-01
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
Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-05
Description

Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units Pramoxine hydrochloride 10 mg

Purpose

first aid antibiotic External Analgesic

Medication Information

Warnings and Precautions

For external use only

Purpose
  • first aid antibiotic
  • External Analgesic
Dosage and Administration

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

Description

Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units Pramoxine hydrochloride 10 mg

Uses

first aid to help prevent infection 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 right away.

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

Section 53413-1

www.drspharmacyusa.com

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 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Inactive Ingredient

Petrolatum

Structured Label Content

Uses

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

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

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)

Section 53413-1 (53413-1)

www.drspharmacyusa.com

Purpose
  • first aid antibiotic
  • External Analgesic
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 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Inactive Ingredient

Petrolatum

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.119511 · Updated: 2026-03-14T23:12:42.073607