Dual Action Cream

SPL v8

SPL

SPL Set ID b84015ae-9c76-b1d7-e053-2a95a90a2cc8

Route

TOPICAL

Published

Effective Date 2025-08-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Neomycin (3.5 mg) Pramoxine (10 mg) Polymyxin B (10000 [USP'U])

Inactive Ingredients

Petrolatum Glyceryl Monostearate Laureth-23 Ethylparaben Water Sodium Lauryl Sulfate Cetostearyl Alcohol Glycerin Light Mineral Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-01-06

Description

Neomycin 3.5mg

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Neomycin 3.5mg

Uses

First Aid to help prevent infection iand for temporary relief of pain or discomfort in minor cuts, scrapes and burns.

Label

Warnings

For external use only. Do not use:

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

Packaging

Questions

For Questions please call 1 888 296 9067

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

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

Product of PRC

This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin Plus Pain Relief

Active Ingredient

Neomycin 3.5mg

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredient:

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monosterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.

Ask A Doctor Before Use

Ask Doctor before use if you have:

Deep or puncture wounds
Animal bites
Serious burns

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

Stop Use and Ask A Doctor If:

Condition persists or gets worse
You need to use longer than 1 week
Symptoms persist for more than 1 week or clear up and occur within a few days.
A rash or other allergive reaction develops

Structured Label Content

Uses

First Aid to help prevent infection iand for temporary relief of pain or discomfort in minor cuts, scrapes and burns.

Label (LABEL)

Purpose

First Aid Antibiotic

Warnings

For external use only. Do not use:

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

Packaging

Questions

For Questions please call 1 888 296 9067

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

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

Product of PRC

This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin Plus Pain Relief

Active Ingredient

Neomycin 3.5mg

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredient:

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monosterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.

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

Ask Doctor before use if you have:

Deep or puncture wounds
Animal bites
Serious burns

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

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

Condition persists or gets worse
You need to use longer than 1 week
Symptoms persist for more than 1 week or clear up and occur within a few days.
A rash or other allergive reaction develops

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURETH-23", "unii": "N72LMW566G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLPARABEN", "unii": "14255EXE39", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First Aid to help prevent infection iand for temporary relief of pain or discomfort in minor cuts, scrapes and burns.", "Purpose": "First Aid Antibiotic", "Warnings": "For external use only. Do not use: If you are allergic to any of the ingredients in the eyes over large areas of the body", "Questions": "For Questions please call 1 888 296 9067", "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", "Distributed By": "T rifecta Pharmaceuticals USA 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 www.trifecta-pharma.com Product of PRC This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin Plus Pain Relief", "Active Ingredient": "Neomycin 3.5mg", "Other Information": "Store at 20° to 25°C (68° to 77°F)", "Inactive Ingredient:": "Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monosterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.", "Ask a Doctor before Use": "Ask Doctor before use if you have: Deep or puncture wounds Animal bites Serious burns", "Keep out of Reach of Children": "If swallowed, get medical help or contact a Poison Control Center right away", "Stop Use and ask a Doctor if:": "Condition persists or gets worse You need to use longer than 1 week Symptoms persist for more than 1 week or clear up and occur within a few days. A rash or other allergive reaction develops"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:50.568833 · Updated: 2026-03-14T23:09:51.959406