Active Ingredient(S)
Benzalkonium Chloride 0.13%
Skin Preparation
FDA Label NDC 51706-962
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Landy International for the product Skin Preparation (NDC 51706-962). 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 active ingredient(s), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic Skin Sanitizer
Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
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.
Other Information
Store product flat and between 68 -77° F (20 - 25° C)
Avoid excessive heat above 104° F (40° C)
Inactive Ingredients
Aloe Barbadenis leaf extract, Aqua, Citric Acid,
Caprylyl Glucoside, Laureth-4, Polyhexanide,
Phenoxyethanol, Triethoxysilylpropyl
Steardimonium Chloride.
* Please review the disclaimer below.
