Mupirocin Ointment

FDA Drug Profile — Mupirocin, DermacinRx Clorhexacin

Drug Details

Generic Name
Mupirocin Ointment
Brand Names
Mupirocin, DermacinRx Clorhexacin
Application Number
ANDA065123
Sponsor
Kesin Pharma Corporation
NDC Codes
2
Dosage Forms
OINTMENT, KIT
Routes
TOPICAL
Active Ingredients
MUPIROCIN

Indications and Usage

INDICATIONS AND USAGE Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes . Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing Uses for the treatment and/or prevention of diaper rash temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS Mupirocin Ointment USP, 2% is not for ophthalmic use. Warnings For external use only. Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away. Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.