FDA Label for Skin Preparation
View Indications, Usage & Precautions
Skin Preparation Product Label
The following document was submitted to the FDA by the labeler of this product Landy International. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Benzalkonium Chloride 0.13%
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.
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