CUADRIDERMA- bacitracin zinc, polymyxin b sulfate, neomycin sulfate, and pramoxine hydrochloride ointment

Cuadriderma by

Drug Labeling and Warnings

Cuadriderma by is a Otc medication manufactured, distributed, or labeled by ProMex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin 500 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	Pain reliever

Uses

helps prevent infection in and temporarily relieves pain due to

• * minor cuts
• * scrapes
• * burns

Warnings

For external use only

Allergy alert

• * do not use if allergic to any of the ingredients

Do not use

• * in or near the eyes
• * on large areas of the body

Ask a doctor before use if you have

• * deep or puncture wounds
• * animal bites
• * serious burns

When using this product

• * do not use longer than 1 week

Stop use and ask a doctor if

• * condition lasts or gets worse
• * symptoms last for more than 7 days or clear up and come back within a few days
• * a rash or other allergic reaction occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years and older:

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

Children under 2 years: ask a doctor

Other information

Store at controlled room temperature 68°-77°F (20°-25°C)

Inactive ingredient

Petrolatum

Questions Comments

1 (305) 653-2700

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

Original

Cuadriderma®
First Aid Antibiotic / Pain Relief Ointment

Net Wt. 1 oz (28.35 g.)

Pro-Mex®

INGREDIENTS AND APPEARANCE

CUADRIDERMA 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58988-1170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [iU]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [iU]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-1170-1	1 in 1 CARTON	05/31/2013
1		28.35 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	05/31/2013

Labeler - ProMex LLC (789974388)