Skin Preparation

Manufacturer
Landy International | Zhangzhou Zhongnan Nursing Products Co.,ltd
Effective date
2020-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:33

Label at a glance#

ProductSkin Preparation
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

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...

Storage and handling

Store product flat and between 68 -77° F (20 - 25° C) Avoid excessive heat above 104° F (40° C)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic Skin Sanitizer

Use

INDICATIONS & USAGE SECTION

For preparation of skin pre and post surgery
Helps reduce bacteria on the skin.

Warnings

WARNINGS SECTION

• 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 SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store product flat and between 68 -77° F (20 - 25° C)
Avoid excessive heat above 104° F (40° C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadenis leaf extract, Aqua, Citric Acid,
Caprylyl Glucoside, Laureth-4, Polyhexanide,
Phenoxyethanol, Triethoxysilylpropyl
Steardimonium Chloride.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51706-962-012021-07-23C16284748780-1c7ccaba7-18fc-fd44-e053-dadaa90aa01b51706-962 Skin Preparation Cloth 0.13% Benzalkonium chloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51706-962-01Skin Preparation0.0325 g in 1 NOT APPLICABLECLOTH0.03251
51706-962-01Skin Preparation2 in 1 BAGCLOTH21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51706-962SKIN PREPARATION (BENZALKONIUM CHLORIDE) CLOTH [LANDY INTERNATIONAL]1Legacy NDC, 2 package rows20201203_b57212b2-054a-0c90-e053-2a95a90a1715.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51706-96251706-962-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b5720fcf-40a7-420c-e053-2a95a90a6707b57212b2-054a-0c90-e053-2a95a90a17152020-12-01WarningsExact identifier
spl id: b5720fcf-40a7-420c-e053-2a95a90a6707
spl set id: b57212b2-054a-0c90-e053-2a95a90a1715

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.