51706-962 Skin Preparation Cloth 0.13% Benzalkonium Chloride

51706-962 Skin Preparation Cloth 0.13% Benzalkonium Chloride
SPL v1
SPL
SPL Set ID b57212b2-054a-0c90-e053-2a95a90a1715
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Phenoxyethanol Laureth-4 Caprylyl Glucoside Polihexanide Triethoxysilylpropyl Steardimonium Chloride Water Aloe Vera Leaf Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-01

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic Skin Sanitizer


Medication Information

Purpose

Antiseptic Skin Sanitizer

Description

Benzalkonium Chloride 0.13%

Use

For preparation of skin pre and post surgery

Helps reduce bacteria on the skin.

Section 50565-1

Keep out of reach of children

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

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)

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

Aloe Barbadenis leaf extract, Aqua, Citric Acid,

Caprylyl Glucoside, Laureth-4, Polyhexanide,

Phenoxyethanol, Triethoxysilylpropyl

Steardimonium Chloride.

Package Label Principal Display Panel


Structured Label Content

Use

For preparation of skin pre and post surgery

Helps reduce bacteria on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children

Purpose

Antiseptic Skin Sanitizer

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

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 (Other information)

Store product flat and between 68 -77° F (20 - 25° C)

Avoid excessive heat above 104° F (40° C)

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

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)


Advanced Ingredient Data


Raw Label Data

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