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Drug Facts
Cuadriderma Ointment
FDA Label NDC 58988-1170
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Promex Llc for the product Cuadriderma (NDC 58988-1170). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, allergy alert, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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.
Otc - Keep Out Of Reach Of Children
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)
* Please review the disclaimer below.
