drug facts

drug facts

SPL v2

SPL

SPL Set ID 395e9db3-dea8-4ba6-b88a-8a7851c5ad90

Route

topical

Published

Effective Date 2011-09-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

bacitracin zinc (500 [iU]) neomycin (3.5 mg) polymyxin b (10000 [iU]) pramoxine (10 mg)

Inactive Ingredients

petrolatum

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2011-09-12

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic

Description

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

Medication Information

Warnings

For external use only

Uses

First aid to help prevent infection and provide temporary relief of pain or discomfort in minor

cuts
scrapes
burns

Purpose

First aid antibiotic

External analgesic

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 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: consult a physician

Other Information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

white petrolatum

Description

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

Principal Display Panel

Triple Antibiotic Ointment + Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic Ointment

Maximum Strength

NET WT 1 oz (28.3 g)

Section 55105-1

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCI 10 mg	External analgesic

Do Not Use

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

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children.

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

Active Ingredients (in Each Gram)

Bacitracin Zinc 500 units

Neomycin 3.5mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Ask A Doctor Before Use If You Have

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Structured Label Content

Warnings

For external use only

Uses

First aid to help prevent infection and provide temporary relief of pain or discomfort in minor

cuts
scrapes
burns

Purpose

First aid antibiotic

External analgesic

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 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: consult a physician

Other Information (Other information)

store at 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

white petrolatum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Triple Antibiotic Ointment + Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic Ointment

Maximum Strength

NET WT 1 oz (28.3 g)

Section 55105-1 (55105-1)

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCI 10 mg	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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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.

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

Bacitracin Zinc 500 units

Neomycin 3.5mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Advanced Ingredient Data

[{"name": "Bacitracin Zinc", "unii": "89Y4M234ES", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "Neomycin", "unii": "I16QD7X297", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Polymyxin B", "unii": "J2VZ07J96K", "classCode": "ACTIB", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "Pramoxine", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "petrolatum", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First aid to help prevent infection and provide temporary relief of pain or discomfort in minor cuts scrapes burns", "55105-1": "Active ingredients (each gram contains) Purpose Bacitracin zinc 500 units First aid antibiotic Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine HCI 10 mg External analgesic", "Purpose": "First aid antibiotic First aid antibiotic First aid antibiotic External analgesic", "Warnings": "For external use only", "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 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: consult a physician", "Do not use": "if you are allergic to any of the ingredients in the eyes over large areas of the body", "Other information": "store at 20°-25°C (68°-77°F)", "Inactive ingredients": "white petrolatum", "PRINCIPAL DISPLAY PANEL": "Triple Antibiotic Ointment + Pain Relief Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl First Aid Antibiotic Ointment Maximum Strength NET WT 1 oz (28.3 g)", "Stop use and ask a doctor if": "you need to use longer than 1 week condition persists or gets worse condition persists for more than 1 week, or clear up and occur again within a few days a rash or other allergic reaction develops", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Active ingredients (in each gram)": "Bacitracin Zinc 500 units Neomycin 3.5mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg", "Ask a doctor before use if you have": "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.058625 · Updated: 2026-03-14T22:52:53.430326