The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Bacitracin With Pain Relief (NDC 59779-537). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredient PurposeBacitracin, USP 500 units..................................................First Aid AntibioticLidocaine 4% w/w..............................................................Pain Reliever
Otc - Purpose
Uses- first aid to help prevent infection in and temporarily relieve pain due to- minor cuts - scrapes - burns
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.
Indications & Usage
Uses- first aid to help prevent infection in and temporarily relieve pain due to- minor cuts - scrapes - burns
Warnings
Warnings For external use onlyDo not use - in the eyes - over large areas of the body - if you are allergic to any of the ingredients - longer than 1 week unless directed by a doctorAsk a doctor before use in the case of a deep puncture wound, animal bites or serious burnsStop use and ask a doctor if - the condition persists or gets worse- a rash or other allergic reaction develops- symptoms last for more than 7 days or clear up and come back within a few daysKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
DirectionsAdults and children 2 years and older- 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 bandageChildren under 2 years ask a doctor
Inactive Ingredient
Inactive Ingredientswhite petrolatum
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