FDA.reportPublic FDA data

Bedside-Care

Manufacturer
Coloplast Corp | Coloplast Corp. | Medline Industries, LP
Effective date
2026-03-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:52:08

Label at a glance#

ProductBedside-Care
Active ingredientBENZETHONIUM CHLORIDE
Label structure3 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For Full-Body Bathing And Perineal Clean-Up

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzethonium Chloride 0.1%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop using this product if:

  • if skin irritation and redness develop
  • if condition persists for more than 7 days, consult a physician.

SPL UNCLASSIFIED SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions Cleanse the affected area according to protocol.

INACTIVE INGREDIENT SECTION

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

Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Cleansing: apply to the affected area and remove with a moist washcloth. Bathing: dispense 3-4 pumps in a basin with warm water and cleanse the skin. Shampooing: pump foam directly on dampened hair, lather and remove with a moist washcloth.

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 ©2007, Coloplast Corp.
Product #7146 Made in the U.S.A.

G7-1277

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11701-053-04

Bedside-Care®Unscented Foam

Bathing & Perineal Skin Cleanser

No-Rinse Foaming
Body Wash, Shampoo
& Incontinent Cleanser

For Full Body
Bathing and Perineal
Clean-Up

Coloplast

4 fl. oz. (118 mL)

Principal Display Panel - 118 mL Bottle Label
Principal Display Panel - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049093benzethonium chloride 0.1 % Topical FoamPSN7
1049093benzethonium chloride 1 MG/ML Topical FoamSCD7
1049093benzethonium chloride 0.1 % Topical FoamSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-053-042020-01-31C16284748780-19d75b9d0-ec74-f424-e053-dadaa90a57ceBedside-Care ® Unscented Foam Bathing & Perineal Skin Cleanser No-Rinse Foaming Body Wash, Shampoo & Incontinent Cleanser
11701-053-052020-01-31C16284748780-19d75b9d0-ec74-f424-e053-dadaa90a57ceBedside-Care ® Unscented Foam Bathing & Perineal Skin Cleanser No-Rinse Foaming Body Wash, Shampoo & Incontinent Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-053-04Bedside-Care118 mL in 1 BOTTLE, SPRAYSHAMPOO1187
11701-053-05Bedside-Care237 mL in 1 BOTTLE, SPRAYSHAMPOO2377

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-053-05ML - Milliliter11701-0530a5fe05e-fba0-442b-a099-405cfe6ac79412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057444
BENZETHONIUMACTIVE MOIETY1VU15B70BP4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP4
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH4
QUATERNIUM-15INACTIVE INGREDIENTE40U03LEM04
QUATERNIUM-52INACTIVE INGREDIENT588EQF3H1P4
SODIUM LAUROAMPHOACETATEINACTIVE INGREDIENTSLK428451L4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11701-05311701-053-04, 11701-053-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
QUATERNIUM-15E40U03LEM0IACT
GLYCERINPDC6A3C0OXIACT
QUATERNIUM-52588EQF3H1PIACT
POLYSORBATE 207T1F30V5YHIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
QUATERNIUM-15QUATERNIUM-15E40U03LEM0LOTION / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0LOTION / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0LOTION / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route
9 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM, AUGMENTED / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM, AUGMENTED / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route
9 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM, AUGMENTED / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates

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
Bedside-CareBENZETHONIUM CHLORIDEColoplast Corpe0cf033c-82fa-4b5a-b2be-5b0d13c0cea02026-03-30WarningsExact identifier
ndc (package): 11701-053-05
ndc (package): 11701-053-04
ndc (product): 11701-053
ndc11 (package): 11701005304
ndc11 (package): 11701005305
spl id: e4462fa9-bb7b-4e05-bfcd-77b5493270a9
spl set id: e0cf033c-82fa-4b5a-b2be-5b0d13c0cea0

Reported adverse events (FAERS/openFDA)#

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