PROPLEX BACITRACIN- bacitracin cream

PROPLEX BACITRACIN by

Drug Labeling and Warnings

PROPLEX BACITRACIN by is a Otc medication manufactured, distributed, or labeled by Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Bacitracin 500 units / gram

Purpose

First aid antibiotic

Use

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
• longer than 1 week unless directed by doctor

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• condition persists or gets worse
• a rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Adults and children 2 years old and older:

• clean affected area
• apply a small amount (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 old:

• ask a doctor

Other information

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

Inactive ingredient

white petrolatum

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC # 67234-059-01

bacitracin
first aid antibiotic

bacitracin zinc 500
units / gram

• Helps prevent infection
  in minor cuts, scrapes,
  & burns

NET WT. 1 oz (28 g)

PRO PLEX

INGREDIENTS AND APPEARANCE

PROPLEX BACITRACIN 
bacitracin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-059
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-059-01	1 in 1 CARTON	03/18/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	03/18/2019

Labeler - Natureplex LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-059)