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

Description

Drug Facts

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Warnings

For external use only

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

mineral oil, petrolatum

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

Use

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

First Aid Antibiotic

Warnings

For external use only

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

mineral oil, petrolatum

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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