0725364b-b243-4891-af2f-a6049366d038

SPL v4
SPL
SPL Set ID 0725364b-b243-4891-af2f-a6049366d038
Route
topical
Published
Effective Date 2024-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
neomycin (3.5 mg)
Inactive Ingredients
mineral oil petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-07

Purpose

First Aid Antibiotic

Description

Drug Facts


Medication Information

Warnings

For external use only

Purpose

First Aid Antibiotic

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Inactive Ingredients

mineral oil, petrolatum

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Do Not Use
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Stop Use and Ask A Doctor If
  • a rash or allergic reaction develops
  • condition worsens or persists
Keep Out of Reach of Children

If ingested, contact a Poison Control Center right away.

Active Ingredient (in Each Gram)

Neomycin Sulfate (3.5 mg Neomycin)

Principal Display Panel – 0.90ml Pouch Label

BE SMART

GET PREPARED®

ANTIBIOTIC OINTMENT

0.03 oz [0.90 g]

Single Use

Made in USA

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.trikits.com00-OIN-21209 Rev. 02

NDC 55550-730-21


Structured Label Content

Warnings

For external use only

Purpose

First Aid Antibiotic

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Inactive Ingredients (Inactive ingredients)

mineral oil, petrolatum

Use

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

Section 42229-5 (42229-5)

Drug Facts

Do Not Use (Do not use)
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • a rash or allergic reaction develops
  • condition worsens or persists
Keep Out of Reach of Children (Keep out of reach of children)

If ingested, contact a Poison Control Center right away.

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

Neomycin Sulfate (3.5 mg Neomycin)

Principal Display Panel – 0.90ml Pouch Label (Principal Display Panel – 0.90mL Pouch Label)

BE SMART

GET PREPARED®

ANTIBIOTIC OINTMENT

0.03 oz [0.90 g]

Single Use

Made in USA

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.trikits.com00-OIN-21209 Rev. 02

NDC 55550-730-21


Advanced Ingredient Data


Raw Label Data

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