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

How Supplied

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

Description

Drug Facts

Medication Information

Warnings

For external use only

Uses

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

cuts
scrapes
burns

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

How Supplied

Product: 50090-6172

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

Description

Drug Facts

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

Inactive Ingredient

white petrolatum

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

Structured Label Content

Warnings

For external use only

Uses

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

cuts
scrapes
burns

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 (Other information)

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

How Supplied (HOW SUPPLIED)

Product: 50090-6172

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

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

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