Western Family®

SPL v1

SPL

SPL Set ID 526f982e-cb51-4460-9c71-a1a5c6828a41

Route

TOPICAL

Published

Effective Date 2013-03-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (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 2012-03-31

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in

minor cuts
scrapes
burns

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 hydrochloride 10 mg	Topical analgesic

Warnings

For external use only

Directions

Adults and children 2 years of age and older:

clean the affected area and dry thoroughly
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 doctor

Do Not Use

in the eyes
over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week

Questions?

Call 1-866-923-4914

Other Information

To open: unscrew cap, pull tab to remove foil seal
store at room temperature
see carton or tube crimp for lot number and expiration date

Inactive Ingredient

white petrolatum

Ask A Doctor Before Use

on deep or puncture wounds, animal bites, or serious burns

Stop Use and Ask A Doctor If

condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days
a rash or other allergic reaction develops

Principal Display Panel 28 G Tube Carton

Triple Antibiotic

(Bacitracin Zinc-Neomycin Sulfate

Polymyxin B Sulfate-Pramoxine HCL)

OINTMENT+ PAIN RELIEF

NET WT 1 OZ

(28g)

First Aid Antibiotic /Topical Pain Reliever

Structured Label Content

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in

minor cuts
scrapes
burns

Section 42229-5 (42229-5)

Drug Facts

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 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 hydrochloride 10 mg	Topical analgesic

Warnings

For external use only

Directions

Adults and children 2 years of age and older:

clean the affected area and dry thoroughly
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 doctor

Do Not Use (Do not use)

in the eyes
over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week

Questions?

Call 1-866-923-4914

Other Information (Other information)

To open: unscrew cap, pull tab to remove foil seal
store at room temperature
see carton or tube crimp for lot number and expiration date

Inactive Ingredient (Inactive ingredient)

white petrolatum

Ask A Doctor Before Use (Ask a doctor before use)

on deep or puncture wounds, animal bites, or serious burns

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

condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days
a rash or other allergic reaction develops

Principal Display Panel 28 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28 g Tube Carton)

Triple Antibiotic

(Bacitracin Zinc-Neomycin Sulfate

Polymyxin B Sulfate-Pramoxine HCL)

OINTMENT+ PAIN RELIEF

NET WT 1 OZ

(28g)

First Aid Antibiotic /Topical Pain Reliever

Advanced Ingredient Data

[{"name": "Bacitracin", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "Neomycin", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Polymyxin B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "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 for the temporary relief of pain or discomfort in minor cuts scrapes burns", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "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 hydrochloride 10 mg Topical analgesic", "Warnings": "For external use only", "Directions": "Adults and children 2 years of age and older: clean the affected area and dry thoroughly 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 doctor", "Do not use": "in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week", "Questions?": "Call 1-866-923-4914", "Other information": "To open: unscrew cap, pull tab to remove foil seal store at room temperature see carton or tube crimp for lot number and expiration date", "Inactive ingredient": "white petrolatum", "Ask a doctor before use": "on deep or puncture wounds, animal bites, or serious burns", "Stop use and ask a doctor if": "condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days a rash or other allergic reaction develops", "PRINCIPAL DISPLAY PANEL - 28 g Tube Carton": "Triple Antibiotic (Bacitracin Zinc-Neomycin Sulfate Polymyxin B Sulfate-Pramoxine HCL) OINTMENT+ PAIN RELIEF NET WT 1 OZ (28g) First Aid Antibiotic /Topical Pain Reliever"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:36.067400 · Updated: 2026-03-14T22:53:25.926266