Triple Antibiotic Ointment
FDA Label NDC 21922-101

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 21922-101). 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), purposes, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask 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)

→ Purposes

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Stop Use And Ask Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredient

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients (In Each Gram)

Bacitracin zinc USP, 500 units

Neomycin 3.5 mg

Polymyxin B sulfate USP, 10,000 units

Pramoxine hydrochloride USP, 10 mg

Purposes

First aid antibiotic

Pain reliever

Uses

First aid to help prevent infection for the temporary relief of pain in minor ■ burns ■ cuts ■ scrapes

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

■ deeper puncture wounds

■ animal bites

■ serious bums

Stop Use And Ask Doctor If

■ you need to use longer than one week

■ condition persists or gets worse
■ rash or other allergic reaction develops
■ symptoms persist for more than one week, or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 finger) on the area 1 to 3 times daily
■ may be covered with a sterile bandage
■ children under 2 years of age: ask a doctor