SKIN PREPARATION- benzalkonium chloride cloth

Skin Preparation by

Drug Labeling and Warnings

Skin Preparation by is a Otc medication manufactured, distributed, or labeled by Landy International, Zhangzhou Zhongnan Nursing Products Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SKIN PREPARATION 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51706-962
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURETH-4 (UNII: 6HQ855798J)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
POLIHEXANIDE (UNII: 322U039GMF)
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51706-962-01	2 in 1 BAG	12/01/2020
1		0.0325 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2020

Labeler - Landy International (545291775)

Establishment
Name	Address	ID/FEI	Business Operations
Zhangzhou Zhongnan Nursing Products Co.,ltd		416376835	manufacture(51706-962)