Pharma Care Pro Sterile Prep Swabstick Povidone-iodine Swab
FDA Label NDC 71884-059
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Enviro Specialty Chemicals Inc for the product Pharma Care Pro Sterile Prep Swabstick Povidone-iodine (NDC 71884-059). 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 drug facts:, active ingredients, purposes, use, warnings:, otc - keep out of reach of children, directions for use, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Povidone-Iodine 10% w/v (equivalent to 1% titratable Iodine)
Purposes
Antiseptic
Use
For the preparation of a patient’s skin prior to surgery, injection, venipuncture/phlebotomy procedural sites, to reduce the risk of bacterial and skin infection, when used as directed.
Warnings:
For external use only. Single use only. For Professional Health Care providers use only. Flammable: keep away from fire or flame.
Do not use
• on patients with known allergies to Iodine
• for lumbar puncture or in contact with the meninges
• on open skin wounds or as a general skin cleanser
Do not use with electrocautery procedure.
When using this product, keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
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 For Use
• use with care in premature infants or infants under 2 months of age — these products may cause irritation or chemical burns.
• maximal recommended treatment area using:
• one single swab stick applicator: approx. 2.5 in × 2.5 in (42 cm²)
• three single swab sticks used sequentially: approx. 5.0 in × 5.0 in (150 cm²)
• tear pouch at side notch to reveal applicator handles. Do not touch applicator tip.
• place foam flat side down on treatment area.
• completely wet the treatment area with antiseptic.
• dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes; use applicator within 2 minutes from opening.
• moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes; use applicator within 2 minutes from opening.
• discard the applicator after a single use along with any unused portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.
Other Information:
• Store at room temperature • Avoid freezing and excessive heat
Inactive Ingredients:
Alkyl glucoside, Citric acid, Glycerin, Nonoxynol-10, Hydroxyethyl cellulose, Potassium iodine, Sodium hydroxide, USP purified water.
Questions?
• www.escbrands.com • call +1(888)-331-8332 (M-F 8 a.m.-5 p.m. EST)
Packaging
Pharma Care Swabstick (71884059 4)
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