Triple Antibiotic Ointment Plus Pain Relief

SPL v2

SPL

SPL Set ID 5bfc7776-1030-48ba-9df4-897c4984c9e6

Route

TOPICAL

Published

Effective Date 2025-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Neomycin (3.5 mg) Bacitracin (500 [iU]) Polymyxin B (10000 [iU]) Pramoxine (10 mg)

Inactive Ingredients

White Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Drug Facts

Purpose

First Aid Antibiotics External analgesic

Medication Information

Purpose

First Aid Antibiotics

External analgesic

Description

Drug Facts

Uses

First Aid to help prevent infection in minor cuts, scrapes and 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 (1-800-222-1222)

Section 50566-9

Stop use and ask a doctor if

you need to use longer thab 1 week
the condition persists or gets worse
rash or other allergic reaction develops

Section 50567-7

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

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:ask a doctor

Do Not Use

Do not use

If you are allergic to any of the ingredients
In the eyes
over large areas of the body

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.L.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

Other Information

To open, unscrew cap, pull tab to remove foil seal.
Store at room temperatue 20° to 25°C (68° to 77° F)
See carton ot tube crimp for Lot Number and Expiry Date

Active Ingredients

Bacitracin Zinc (400 units in each gram)

Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

Polymyxin B Sulfate (5000 units per gram)

Pramoxine HCl USP (10mg in each gram)

Inactive Ingredients

White Petrolatum

Package Label Principal Display Panel

Structured Label Content

Uses

First Aid to help prevent infection in minor cuts, scrapes and 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 (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask a doctor if

you need to use longer thab 1 week
the condition persists or gets worse
rash or other allergic reaction develops

Section 50567-7 (50567-7)

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Purpose

First Aid Antibiotics

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:ask a doctor

Do Not Use (Do not use)

Do not use

If you are allergic to any of the ingredients
In the eyes
over large areas of the body

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.L.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

Other Information (Other information)

To open, unscrew cap, pull tab to remove foil seal.
Store at room temperatue 20° to 25°C (68° to 77° F)
See carton ot tube crimp for Lot Number and Expiry Date

Active Ingredients (Active ingredients)

Bacitracin Zinc (400 units in each gram)

Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

Polymyxin B Sulfate (5000 units per gram)

Pramoxine HCl USP (10mg in each gram)

Inactive Ingredients (Inactive ingredients)

White Petrolatum

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "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 in minor cuts, scrapes and 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 (1-800-222-1222)", "50566-9": "Stop use and ask a doctor if you need to use longer thab 1 week the condition persists or gets worse rash or other allergic reaction develops", "50567-7": "Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns", "Purpose": "First Aid Antibiotics 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: ask a doctor", "Do not use": "Do not use If you are allergic to any of the ingredients In the eyes over large areas of the body", "Questions?": "Contact 1-800-707-4621 Manufactured in India by: Gopaldas Visram & Company Limited. Plot No. A327, T.T.C. Indl. Area, M.L.D.C. Mahape, Navi Mumbai - 400710. Mfg. Lic. No.: KD/503", "Other information": "To open, unscrew cap, pull tab to remove foil seal. Store at room temperatue 20° to 25°C (68° to 77° F) See carton ot tube crimp for Lot Number and Expiry Date", "Active ingredients": "Bacitracin Zinc (400 units in each gram) Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram) Polymyxin B Sulfate (5000 units per gram) Pramoxine HCl USP (10mg in each gram)", "Inactive ingredients": "White Petrolatum"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:21.217237 · Updated: 2026-03-14T23:12:34.529887