The following Structured Product Label (SPL) was submitted to the FDA by Jiangsu Province Jianerkang Medical Dressing Co.,ltd for the product Obstetrical Antiseptic (NDC 34645-5002). 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 package label.principal display panel, otc - active ingredient, otc - purpose, otc - when using, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Package Label.Principal Display Panel
Cat. 40000-200A NDC 34645-5002-3 Qty.1eaObstetrical Antiseptic ToweletteAntiseptic * For Single Use OnlyContains: Benzalkonium Chloride 0.13% w/wFor External Use Only * FOR PROFESSIONAL AND HOSPITAL USECaution: Keep out of reach of childrenDistributed by:Cardinal HealthDublin OH, 43017 USAMade in China
Image of Pouch Label
Otc - Active Ingredient
Active ingredientBenzalkonium Chloride, 0.13% w/w
Otc - Purpose
PurposeFirst Aid Antiseptic
Otc - When Using
UseFirst aid antiseptic to help prevent skin infection in minor cuts, scrapes, and burns
Warnings
WarningsFor external use only.
Otc - Do Not Use
Do not usein the eyes or apply over large areas of the bodylonger than 1 week unless directed by a doctor. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
Otc - Stop Use
Stop use and consult a doctorif the condition persists or gets worse
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
DirectionsClean the affected areaApply a small amount of this product on the area 1 to 3 times dailyMay be covered with a sterile bandage when dry
Inactive Ingredient
Inactive ingredients
purified water, sodium bicarbonate
* Please review the disclaimer below.
