Active Ingredients(In Each Gram)
Bacitracin Zinc 400 units
Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)
Polymyxin B sulfate 5000 units
Oopsie Ointment
FDA Label NDC 87251-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 4 Visions Llc for the product Oopsie (NDC 87251-007). 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 active ingredients(in each gram), purpose, uses, warnings, do not use, ask a physician before use in case of, stop use and consult a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
Uses
■ first aid to help prevent infection in ■ minor cuts ■ scrapes ■ burns
Warnings
For external use only
Do Not Use
■ in the eyes ■ if you are allergic to any of the ingredients ■ over large areas of the body ■ longer than 1 week unless directed by a doctor
Ask A Physician Before Use In Case Of
■ deep or puncture wounds ■ animal bites ■ serious burns
Stop Use And Consult A Doctor If
■ the condition persists or gets worse ■ a rash or other allergic reaction develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 1 to 3 times daily ■ may be covered with a sterile bandage
Other Information
■ store at room temperature 59-86F (15-30°C) ■ avoid excessive heat and humidity
Inactive Ingredients
White Petrolatum
* Please review the disclaimer below.
