Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e1561623-c792-4cb9-bfc1-6d37d1f4bf66
Route
TOPICAL
Published
Effective Date 2013-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Neomycin (3.5 mg)
Inactive Ingredients
Cetyl Alcohol Squalane Light Mineral Oil Petrolatum .alpha.-tocopherol Acetate, D- Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-05

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 in minor:

  • cuts
  • scrapes
  • burns
Purposes

First aid antibiotic

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 finer) 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
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than one week unless directed by a doctor
Package Label

Antibiotic Ointment

Other Information
  • store at room temperature

Inactive Ingredients

Cetyl alcohol, Light Mineral Oil, Methylparaben, Propylparaben, Squalane, Tocopheryl acetate, White petrolatum

Consult A Doctor in Case Of

deep or puncture woundsanimal bitesserious burns

Stop Use and Ask A Doctor If

the condition persists or gets worsea rash or other allergic reaction occurs

Keep Out of Reach of Children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Active Ingredient (in Each Gram)

Neomycin 3.5mg


Structured Label Content

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Purposes

First aid antibiotic

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 finer) 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)
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than one week unless directed by a doctor
Package Label (Package label)

Antibiotic Ointment

Other Information (Other information)
  • store at room temperature

Inactive Ingredients (Inactive ingredients)

Cetyl alcohol, Light Mineral Oil, Methylparaben, Propylparaben, Squalane, Tocopheryl acetate, White petrolatum

Consult A Doctor in Case Of (Consult a doctor in case of)

deep or puncture woundsanimal bitesserious burns

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

the condition persists or gets worsea rash or other allergic reaction occurs

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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

Neomycin 3.5mg


Advanced Ingredient Data


Raw Label Data

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