NATUREPLEX ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate cream

NATUREPLEX ANTIBIOTIC by

Drug Labeling and Warnings

NATUREPLEX ANTIBIOTIC 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

Active ingredients (in each gram)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic

Use

First aid to help prevent the risk of infection in minor cuts, scrapes, and 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 1 week
• condition persists or gets worse
• rash or other allergic reaction develops

If pregnant or breast-feeding, ask a health professional before use.

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

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 up to 3 times daily
• may be covered with a sterile bandage

Other information

• store at 15 to 30°C (59 to 86°F)
• Tamper Evident: DO NOT USE IF FLAPS ON CARTON ARE NOT SEALED OR MISSING

Inactive ingredient

petrolatum

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

Natureplex™
DUAL ANTIBIOTIC

Antibiotic
Ointment
1
2

BACITRACIN ZINC POLYMYXIN B SULFATE

Dual Action
First Aid

NET WT 0.5 Oz (14g)

INGREDIENTS AND APPEARANCE

NATUREPLEX ANTIBIOTIC 
bacitracin zinc and polymyxin b sulfate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-077
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 U  in 14 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 U  in 14 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-077-01	1 in 1 CARTON	09/28/2021
1		14 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	09/28/2021

Labeler - Natureplex LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-077)