Sunmark Triple Antibiotic Plus Pain Relief

SPL v2

SPL

SPL Set ID 01131ba6-6d5b-4710-bec3-ba1769c08c79

Route

TOPICAL

Published

Effective Date 2024-10-22

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 DRUG Completed Since 2012-03-31 Until 2027-08-31

Description

Drug Facts

How Supplied

Product: 50090-6172 NDC: 50090-6172-0 28.4 g in a TUBE / 36 in a CASE

Medication Information

How Supplied

Product: 50090-6172

NDC: 50090-6172-0 28.4 g in a TUBE / 36 in a CASE

Description

Drug Facts

Uses

first aid to help prevent infection and for 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 50566-9

Stop use and ask a doctor if

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

Section 50567-7

When using this product

do not use in the eyes
do not apply over large areas of the body

Section 50569-3

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Section 50570-1

Do not useif you are allergic to any of the ingredients

Section 55105-1

Active ingredients (in each gram)	Purposes
Bacitracin 500 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B 10,000 units	First aid antibiotic
Pramoxine HCl 10 mg	Topical pain reliever

Warnings

For external use only

Directions

unscrew cap and pull tab to remove foil seal
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: ask a doctor

Other Information

store at controlled room temperature 15°-30°C (59°-86°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredient

white petrolatum

Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate, and Pramoxine Hydrochloride

Structured Label Content

Uses

first aid to help prevent infection and for 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 50566-9 (50566-9)

Stop use and ask a doctor if

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

Section 50567-7 (50567-7)

When using this product

do not use in the eyes
do not apply over large areas of the body

Section 50569-3 (50569-3)

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Section 50570-1 (50570-1)

Do not useif you are allergic to any of the ingredients

Section 55105-1 (55105-1)

Active ingredients (in each gram)	Purposes
Bacitracin 500 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B 10,000 units	First aid antibiotic
Pramoxine HCl 10 mg	Topical pain reliever

Warnings

For external use only

Directions

unscrew cap and pull tab to remove foil seal
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: ask a doctor

How Supplied (HOW SUPPLIED)

Product: 50090-6172

NDC: 50090-6172-0 28.4 g in a TUBE / 36 in a CASE

Other Information (Other information)

store at controlled room temperature 15°-30°C (59°-86°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredient (Inactive ingredient)

white petrolatum

Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate, and Pramoxine Hydrochloride (polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride)

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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"}]

Raw Label Data

All Sections (JSON)

{"Uses": "first aid to help prevent infection and for 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", "50566-9": "Stop use and ask a doctor if you need to use for more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days rash or other allergic reaction develops", "50567-7": "When using this product do not use in the eyes do not apply over large areas of the body", "50569-3": "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns", "50570-1": "Do not use if you are allergic to any of the ingredients", "55105-1": "Active ingredients (in each gram) Purposes Bacitracin 500 units First aid antibiotic Neomycin 3.5 mg First aid antibiotic Polymyxin B 10,000 units First aid antibiotic Pramoxine HCl 10 mg Topical pain reliever", "Warnings": "For external use only", "Directions": "unscrew cap and pull tab to remove foil seal 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: ask a doctor", "HOW SUPPLIED": "Product: 50090-6172 NDC: 50090-6172-0 28.4 g in a TUBE / 36 in a CASE", "Other information": "store at controlled room temperature 15°-30°C (59°-86°F) see carton or tube crimp for lot number and expiration date", "Inactive ingredient": "white petrolatum"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:58.494565 · Updated: 2026-03-14T23:04:21.109870