vitacilina first aid antibiotic

vitacilina first aid antibiotic
SPL v3
SPL
SPL Set ID 93fb9e05-f78c-4d37-b6f1-926cbcb2e7a7
Route
topical
Published
Effective Date 2022-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 U) neomycin (3.5 mg) polymyxin b (5000 U)
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-07-01 Until 2028-01-26

Purpose

First aid antibiotic

Description

Bacitracin Zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units


Medication Information

Warnings

For external use only.

Purpose

First aid antibiotic

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
Other Information
  • store at 15 to 30°C (59 to 86°F )
  • DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING. Tamper Evident:
Description

Bacitracin Zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units

Use

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

Do Not Use
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Inactive Ingredient

petrolatum

Package Labeling 14g

Package Labeling 28g

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Stop Use and Ask A Doctor If
  • you need to use longer than 1 week 
  • condition persists to gets worse
  • rash or other allergic reaction develops
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center 

Active Ingredient (in Each Gram)

Bacitracin Zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Ask A Doctor Before Use If You Have
  • deep or puncture wounds 
  • animal bites 
  • serious burns

Structured Label Content

Warnings

For external use only.

Purpose

First aid antibiotic

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
Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F )
  • DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING. Tamper Evident:
Use

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

Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Inactive Ingredient (Inactive ingredient)

petrolatum

Package Labeling 14g

Package Labeling 28g

Add image transcription here...

Add image transcription here...

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use longer than 1 week 
  • condition persists to gets worse
  • 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 

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

Bacitracin Zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds 
  • animal bites 
  • serious burns

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)