The following Structured Product Label (SPL) was submitted to the FDA by Allied Trade Link Llc for the product Bacitracin (NDC 84387-002). 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 ingridient, uses, warnings, do not use, ask a doctor, keep out of reach of children, direction, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient (in each gram) Purpose
Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic
Uses
First aid to help prevent infection in minor cuts, scrapes, and burns
For External Use Only
Do not use In the eyes or over large areas of the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a
doctor.
Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal Store at room temperature
See crimp of tube or carton for Lot Number and Expiry Date Preserve in well-closed containers, preferably at controlled room temperature.
Mineral Oil, Paraffin, White Petrolatum
Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by
a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting,
ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for
2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails
Active Ingredient Purpose
Miconazole Nitrate 2% ........................................................................................................................................................................................................................................................................... Antifungal
Bacitricin (Bacitricin)
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