Triple Antibiotic Ointment
FDA Label NDC 21922-093

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Encube Ethicals, Inc. for the product Triple Antibiotic (NDC 21922-093). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each gram), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Gram)

Bacitracin Zinc USP, 400 units

Neomycin 3.5 mg                                      

Polymyxin B Sulfate USP, 5,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor

  • cuts
    • scrapes
    • burns

Warnings

For external use only.

Do Not Use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask A Doctor Before Use If You Have

■ deep or puncture wounds

■ animal bites

■ serious burns

Stop Use And Ask A Doctor If

■ you need to use longer than one week

■ condition persists or 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 (1-800-222-1222) right away.

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°C to 30°C (59°F to 86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient

white petrolatum

Questions Or Comments?

Call 1-833-285-4151

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Triple Antibiotic Ointment

(Bacitracin zinc - Neomycin sulfate - Polymyxin B sulfate Ointment)

First aid antibiotic

NDC 21922-093-04

Net wt. 0.5 oz (14g)

14-gm-cart (14 Gm Cart)

14-gm-cart (14 Gm Cart)


Triple Antibiotic Ointment

(Bacitracin zinc - Neomycin sulfate - Polymyxin B sulfate Ointment)

First aid antibiotic

NDC 21922-093-05

Net wt. 1 oz (28g)


Cart-14gm (28 Gm Cart)

Cart-14gm (28 Gm Cart)

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