topco associates llc. triple antibiotic ointment drug facts

SPL v4

SPL

SPL Set ID 5e0fc39b-e6d4-4543-8afc-2881e2f85f9b

Route

topical

Published

Effective Date 2022-02-28

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: yellow

Marketing Status

otc monograph drug active Since 2020-03-15

Purpose

First aid antibiotic External analgesic

Description

Bacitracin zinc 500 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg

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

Purpose

First aid antibiotic

External analgesic

Directions

•
adults and children 2 years of age or 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 20-25°C (68-77°F)

Description

Bacitracin zinc 500 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg

Do Not Use

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

Inactive Ingredient

white petrolatum

Questions Or Comments?

1-888-423-0139

Stop Use and Ask A Doctor If

•
you need to use longer 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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Active Ingredients (in Each Gram)

Bacitracin zinc 500 units

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Ask A Doctor Before Use If You Have

•
deep or puncture wounds
•
animal bites
•
serious burns

Package/label Principal Display Panel

COMPARE TO NEOSPORIN® + PAIN RELIEF

ACTIVE INGREDIENTS

First Aid Antibiotic & Pain Relieving Ointment

Helps Prevent Infection in Minor Cuts, Scrapes & Burns

Maximum Strength

TopCare_® health

MAXIMUM STRENGTH

Triple Antibiotic Ointment + Pain Relief

BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCl

First Aid Antibiotic / Pain Relieving Ointment

NET WT 1 OZ (28 g)

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

Purpose

First aid antibiotic

External analgesic

Directions

•
adults and children 2 years of age or 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 20-25°C (68-77°F)

Do Not Use (Do not use)

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

Inactive Ingredient (Inactive ingredient)

white petrolatum

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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
•
symptoms persist for more than 1 week, or clear up and occur again within a few days
•
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. (1-800-222-1222)

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

Bacitracin zinc 500 units

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

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

•
deep or puncture wounds
•
animal bites
•
serious burns

Package/label Principal Display Panel (Package/Label Principal Display Panel)

COMPARE TO NEOSPORIN® + PAIN RELIEF

ACTIVE INGREDIENTS

First Aid Antibiotic & Pain Relieving Ointment

Helps Prevent Infection in Minor Cuts, Scrapes & Burns

Maximum Strength

TopCare_® health

MAXIMUM STRENGTH

Triple Antibiotic Ointment + Pain Relief

BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCl

First Aid Antibiotic / Pain Relieving Ointment

NET WT 1 OZ (28 g)

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "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": "[USP'U]", "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 temporary relief of pain or discomfort in minor: • cuts • scrapes • burns", "Purpose": "First aid antibiotic External analgesic", "Warnings": "For external use only.", "Directions": "• adults and children 2 years of age or 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", "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 ingredient": "white petrolatum", "Questions or comments?": "1-888-423-0139", "Stop use and ask a doctor if": "• you need to use longer 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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "Active ingredients (in each gram)": "Bacitracin zinc 500 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg", "Ask a doctor before use if you have": "• deep or puncture wounds • animal bites • serious burns", "Package/Label Principal Display Panel": "COMPARE TO NEOSPORIN® + PAIN RELIEF ACTIVE INGREDIENTS First Aid Antibiotic & Pain Relieving Ointment Helps Prevent Infection in Minor Cuts, Scrapes & Burns Maximum Strength TopCare ® health MAXIMUM STRENGTH Triple Antibiotic Ointment + Pain Relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCl First Aid Antibiotic / Pain Relieving Ointment NET WT 1 OZ (28 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.878711 · Updated: 2026-03-14T23:03:52.479021