Pharma-care Skin Preparation Cloths Cloth
FDA Label NDC 71884-015
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 Skin Preparation Cloths (NDC 71884-015). 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, otc - active ingredient, otc - purpose, indications & usage, warnings:, other information:, inactive ingredients:, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
ACTIVE INGREDIENT: Benzalkonium Chloride 0.13
Otc - Purpose
PURPOSE: Antiseptic Skin Sanitizer
Indications & Usage
USES: For preparation of skin pre and post surgery
Helps reduce bacteria on the skin.
Warnings:
• Single use only
• Do not freeze
• For external use only
• Do not use in ears, eyes or mouth
• Use with care in premature infants or infants under 2 months of age
• Avoid contact with the eyes. In case of contact, flush eyes with water
• Stop use and ask a doctor if skin redness or irritation develops
• If swallowed, get medical help immediately
Other Information:
Store product flat and between 68-77° F (20 - 25° C)
Avoid excessive heat above 104° F (40° C)
Inactive Ingredients:
Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.
Questions?
Call +1(888) 331-8332
Mon-Fri 9.00 AM - 5.00 PM (EST)
Directions:
DO NOT MICROWAVE
Product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.
Using sterile scissors, cut off end seal of satchel.
Transfer contents onto prep table.To reduce the risk of cloth contamination, avoid contact between cloths and the outside of package.
Use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be
contaminated. Use the second cloth to prepare larger areas.
For dry surgical sites such as abdomen or arm, use one cloth to cleanse each 5 in. x 5 in. area (approx. 161 sq. cm) of skin to be prepared.
Vigorously scrub skin back and forth for 3 minutes, completely wetting the treatment area. Discard cloth. Allow area to air dry for one (1)
minute. Do not rinse.
For moist surgical sites such as inguinal fold, use one cloth to cleanse 2 in. x 5 in. (approx. 65 sq. cm) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting the treatment area. Discard cloth. Allow area to air dry for one (1) minute. Do not rinse.
Discard each cloth after single use.
After satchel has been opened, discard any unused cloths.
Packaging
Phcare1 (71884015 2)
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