Bacitracin by Proficient Rx LP BACITRACIN ointment

Bacitracin by

Drug Labeling and Warnings

Bacitracin by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient               Purpose
Bacitracin 500 Units                Antibiotic

Warnings:

For external use only

Dosage and Administration:

• clean the affected areas
• apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
• may be covered with a sterile bandage
  

Stop use and ask a doctor if

•  the condition persists or gets worse, or if a rash or other allergic reaction develops.

Do not use:

• if you are allergic to any of the ingredients
  
• in the eyes
• over large areas of the body
• longer than 1 week unless directed by a doctor
  

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Purpose

First aid to help prevent infection in:
Minor cuts
scrapes
burns

Indications and Usage

Ask a doctor before use:

• in case of deep or puncture wounds
• animal bites
• serious burns

Other information

• store at controlled room temperature 15°-30° C (59°-86° F)

Inactive ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Relabeled By:

Proficient Rx LP Thousand Oaks, CA 91320

Bacitracin Ointment:

bacitracin-galentic-ointment-01.jpg

INGREDIENTS AND APPEARANCE

BACITRACIN 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-299(NDC:67777-219)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-299-01	28.35 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	12/01/2009

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079502574	REPACK(63187-299) , RELABEL(63187-299)