pharma + care patient preoperative & postoperative skin preparation cloths

pharma + care patient preoperative & postoperative skin preparation cloths
SPL v2
SPL
SPL Set ID 324ec648-59f9-46c2-ab7a-7ec6ba42dd42
Route
topical
Published
Effective Date 2020-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
aloe vera leaf water citric acid monohydrate caprylyl glucoside laureth-4 polihexanide phenoxyethanol triethoxysilylpropyl steardimonium chloride

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-08-14

Description

ACTIVE INGREDIENT : Benzalkonium Chloride 0.13


Medication Information

Active Ingredient

ACTIVE INGREDIENT: Benzalkonium Chloride 0.13

Indications and Usage

USES: For preparation of skin pre and post surgery

Helps reduce bacteria on the skin.

Description

ACTIVE INGREDIENT : Benzalkonium Chloride 0.13

Questions?

Call +1(888) 331-8332

Mon-Fri 9.00 AM - 5.00 PM (EST)

Section 42229-5

RINSE FREE

LONG LASTING, ALCOHOL-FREE

PROTECTION FROM MICROORGANISMS

Formulated and enhanced with

Zetrisil

A PROPRIETARY SILICONE QUATERNARY SOLUTION

+ Fast-acting, 15-second formula

+ Last up to 4 hours

+ No natural rubber or latex

+ Non-sterile

DO NOT MICROWAVE

Please dispose of used wipes responsibly.

Do not dispose used wipes down the toilet.

Not made with natural rubber latex.

ESC BRANDS

DISTRIBUTED BY: ESC BRANDS, LLC.

OLD HARGRAVE ROAD, SUITE B

LEXINGTON, NC 27295

888-331-8332

www.escbrands.com

FORMULATED IN THE USA

MADE IN CHINA

Section 55105-1

PURPOSE: Antiseptic Skin Sanitizer

Packaging

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

Drug Facts

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


Structured Label Content

Active Ingredient (55106-9)

ACTIVE INGREDIENT: Benzalkonium Chloride 0.13

Indications and Usage (34067-9)

USES: For preparation of skin pre and post surgery

Helps reduce bacteria on the skin.

Questions? (QUESTIONS?)

Call +1(888) 331-8332

Mon-Fri 9.00 AM - 5.00 PM (EST)

Section 42229-5 (42229-5)

RINSE FREE

LONG LASTING, ALCOHOL-FREE

PROTECTION FROM MICROORGANISMS

Formulated and enhanced with

Zetrisil

A PROPRIETARY SILICONE QUATERNARY SOLUTION

+ Fast-acting, 15-second formula

+ Last up to 4 hours

+ No natural rubber or latex

+ Non-sterile

DO NOT MICROWAVE

Please dispose of used wipes responsibly.

Do not dispose used wipes down the toilet.

Not made with natural rubber latex.

ESC BRANDS

DISTRIBUTED BY: ESC BRANDS, LLC.

OLD HARGRAVE ROAD, SUITE B

LEXINGTON, NC 27295

888-331-8332

www.escbrands.com

FORMULATED IN THE USA

MADE IN CHINA

Section 55105-1 (55105-1)

PURPOSE: Antiseptic Skin Sanitizer

Packaging

Warnings: (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

Drug Facts (DRUG FACTS)

Directions: (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)

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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


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