1164ub-10

1164ub-10
SPL v1
SPL
SPL Set ID 0f9e087b-6e86-a3c7-e063-6394a90ac8d4
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Neomycin (5 mg)
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-30
Description

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Label

1164UB-10

Use(s)

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For External Use Only

Directions

• 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

Do Not Use

• In the eyes or over large areas of the body

• If you are allergic to any of the ingredients

• Longer than 1 week unless directed by a doctor

Questions?

1-888-396-2739 Monday - Friday, 9AM - 5PM EST.

Other Information

• Store at room temperature between 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if seal is torn, cut, or opened.

Inactive Ingredient(s)

White Petrolatum

Ask A Doctor Before Use If

You have deep or puncture wounds, animal bites, or serious burns

Stop Use and Ask A Doctor If

• The condition persists or gets worse

• A rash or other allergic reaction develops

Keep Out of Reach of Children

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

Active Ingredient (in Each Gram)

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Structured Label Content

Label

1164UB-10

Use(s)

First aid to help prevent infection in minor cuts, scrapes, and burns

Purpose

First Aid Antibiotic

Warnings

For External Use Only

Directions

• 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

Do Not Use (Do not use)

• In the eyes or over large areas of the body

• If you are allergic to any of the ingredients

• Longer than 1 week unless directed by a doctor

Questions?

1-888-396-2739 Monday - Friday, 9AM - 5PM EST.

Other Information

• Store at room temperature between 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if seal is torn, cut, or opened.

Inactive Ingredient(s)

White Petrolatum

Ask A Doctor Before Use If (Ask a doctor before use if)

You have deep or puncture wounds, animal bites, or serious burns

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

• The condition persists or gets worse

• A 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 (1-800-222-1222) right away.

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:45.151015 · Updated: 2026-03-14T23:02:27.804765