drug facts

drug facts
SPL v2
SPL
SPL Set ID 8cbac580-9520-4634-8316-02eb6818bc8f
Route
topical
Published
Effective Date 2021-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [USP'U]) neomycin (3.5 mg) polymyxin b (5000 [USP'U])
Inactive Ingredients
white petrolatum

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2021-10-22

Purpose

First aid antibiotic

Description

(in each gram) Bacitracin Zinc (400 units Bacitracin) Neomycin sulfate (3.5 mg Neomycin) Polymyxin B Sulfate (Polymyxin B 5000 units)


Medication Information

Warnings

For external use only

Uses

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

Purpose

First aid antibiotic

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

(in each gram) Bacitracin Zinc (400 units Bacitracin) Neomycin sulfate (3.5 mg Neomycin) Polymyxin B Sulfate (Polymyxin B 5000 units)

Section 50566-9

Stop use and ask a doctor if

  • a rash or allergic reaction develops
  • condition worsens or persists
Do Not Use
  • internally
  • 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
Active Ingredients

(in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Inactive Ingredient

petrolatum

Keep Out of Reach of Children

If ingested, contact a Poison Control Center right away.

Principal Display Panel 0.9g Pouch Label

E+R Ever Ready

First Aid

Triple Antibiotic

Ointment

0.9 g (1/32 oz.)

Contact us: 800-325-4655


Structured Label Content

Warnings

For external use only

Uses

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

Purpose

First aid antibiotic

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • a rash or allergic reaction develops
  • condition worsens or persists
Do Not Use (Do not use)
  • internally
  • 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
Active Ingredients (Active ingredients)

(in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Inactive Ingredient (Inactive ingredient)

petrolatum

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

If ingested, contact a Poison Control Center right away.

Principal Display Panel 0.9g Pouch Label (Principal Display Panel - 0.9g Pouch Label)

E+R Ever Ready

First Aid

Triple Antibiotic

Ointment

0.9 g (1/32 oz.)

Contact us: 800-325-4655


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)