Bedside-care

Bedside-care
SPL v3
SPL
SPL Set ID a5ec24bc-30cf-46d2-9048-07957be07d27
Route
TOPICAL
Published
Effective Date 2010-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (1 mL)
Inactive Ingredients
Citric Acid Edetate Sodium Quaternium-15 Glycerin Quaternium-52 Polysorbate 20 Cocamidopropyl Betaine Sodium Lauroamphoacetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-06-15

Description

For Perineal Clean-Up


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses Protects against the risk of bacterial contamination in minor cuts, scrapes and burns.

Dosage and Administration

Directions Cleanse the affected area according to protocol.

Description

For Perineal Clean-Up

Section 42229-5

For Perineal Clean-Up

Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop using this product:

  • if skin irritation and redness develop
  • if condition persists for more than 72 hours, consult a physician.
Section 50567-7

When using this product: do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.

Section 51727-6

Inactive ingredients water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, citric acid, quaternium-52, quaternium-15, tetrasodium EDTA

Protocol: Shake well before use. Cleansing: Spray on the affected perineal area and remove with a moist washcloth. Aids in the removal of urine, feces and other foreign material. Ostomy/Incontinence Appliance: To help control odor, spray into appliance before and after use.

Manufactured by: Coloplast A/S

DK-3050 Humlebaek, Denmark

Distributed by: Coloplast Corp.

Minneapolis, MN 55411 U.S.A.

1-800-533-0464 www.us.coloplast.com

Product #1453 ©2009-2, Coloplast Corp.

Made in the U.S.A.

B9-1383

Section 51945-4

PRINCIPAL DISPLAY PANEL - NET WT. 8 fl. oz. (237mL)

NDC 11701-059-05

Bedside-Care ® Perineal Wash

Perineal Skin Cleanser

No-Rinse

Incontinent Cleanser

For Perineal Clean-Up

Coloplast

NET WT. 8 fl. oz. (237mL)

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

Benzethonium Chloride 0.1%


Structured Label Content

Indications and Usage (34067-9)

Uses Protects against the risk of bacterial contamination in minor cuts, scrapes and burns.

Dosage and Administration (34068-7)

Directions Cleanse the affected area according to protocol.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

For Perineal Clean-Up

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop using this product:

  • if skin irritation and redness develop
  • if condition persists for more than 72 hours, consult a physician.
Section 50567-7 (50567-7)

When using this product: do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.

Section 51727-6 (51727-6)

Inactive ingredients water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, citric acid, quaternium-52, quaternium-15, tetrasodium EDTA

Protocol: Shake well before use. Cleansing: Spray on the affected perineal area and remove with a moist washcloth. Aids in the removal of urine, feces and other foreign material. Ostomy/Incontinence Appliance: To help control odor, spray into appliance before and after use.

Manufactured by: Coloplast A/S

DK-3050 Humlebaek, Denmark

Distributed by: Coloplast Corp.

Minneapolis, MN 55411 U.S.A.

1-800-533-0464 www.us.coloplast.com

Product #1453 ©2009-2, Coloplast Corp.

Made in the U.S.A.

B9-1383

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL - NET WT. 8 fl. oz. (237mL)

NDC 11701-059-05

Bedside-Care ® Perineal Wash

Perineal Skin Cleanser

No-Rinse

Incontinent Cleanser

For Perineal Clean-Up

Coloplast

NET WT. 8 fl. oz. (237mL)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Benzethonium Chloride 0.1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)