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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cuadriderma®

Drug Facts

Active ingredients (in each gram)Purpose
Bacitracin 500 unitsFirst aid antibiotic
Neomycin 3.5 mgFirst aid antibiotic
Polymyxin B 10,000 unitsFirst aid antibiotic
Pramoxine hydrochloride 10 mgPain 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®

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton
CUADRIDERMA 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate, and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [iU]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [iU]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58988-1170-11 in 1 CARTON05/31/2013
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B05/31/2013
Labeler - ProMex LLC (789974388)

Revised: 1/2022
Document Id: 4d1e0271-73eb-4265-a701-33a742b81483
Set id: 4fa99b96-ab4b-4523-82bc-343dbaf39fb6
Version: 3
Effective Time: 20220125
 
ProMex LLC