FDA.reportPublic FDA data

Bedside-Care

Manufacturer
Coloplast Manufacturing US, LLC | Coloplast Corp
Effective date
2011-06-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:28:36

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, scrapes 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 skin irritation and redness develop
  • if condition persists for more than 72 hours, 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 the 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 water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, quaternium-52, citric acid, quaternium-15, fragrance, tetrasodium EDTA, green 5

Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Bathing: dispense 3-4 sprays in a basin with warm water and cleanse the skin. Shampooing: spray directly on dampened hair, lather and remove with a mois washcloth. Cleansing: apply to the affected perineal area 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
Product #1762 ©2009-2, Coloplast Corp.
Made in the U.S.A.

B9-612

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 11701-020-05

Bedside-Care®

No-Rinse Cleanser

No-Rinse Body Wash, Shampoo &-Incontinent Cleanser

For Full Body Bathing and Perineal Clean-Up

Coloplast

8 fl. oz. (237 mL)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-020-042019-10-29C16284748780-1960f7f55-cc35-8e05-e053-dbdaa90a074aBedside-Care ® No-Rinse Cleanser No-Rinse Body Wash, Shampoo &-Incontinent Cleanser
11701-020-052019-10-29C16284748780-1960f7f55-cc35-8e05-e053-dbdaa90a074aBedside-Care ® No-Rinse Cleanser No-Rinse Body Wash, Shampoo &-Incontinent Cleanser
11701-020-092019-10-29C16284748780-1960f7f55-cc35-8e05-e053-dbdaa90a074aBedside-Care ® No-Rinse Cleanser No-Rinse Body Wash, Shampoo &-Incontinent Cleanser

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-020-04ML - Milliliter11701-0201981a7cf-3c7b-4bda-9b42-eaec55c063d212012-07-24
11701-020-05ML - Milliliter11701-020f6570782-0daf-4b97-9234-166a62aa171a12012-07-24
11701-020-09ML - Milliliter11701-020bf8fd281-4754-4d54-9a6e-6284c8e4ccfe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057443
BENZETHONIUMACTIVE MOIETY1VU15B70BP3
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QP3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX3
D&C GREEN NO. 5INACTIVE INGREDIENT8J6RDU8L9X3
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH3
QUATERNIUM-15INACTIVE INGREDIENTE40U03LEM03
QUATERNIUM-52INACTIVE INGREDIENT588EQF3H1P3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
11701-02011701-020-04, 11701-020-05, 11701-020-09

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
D&C GREEN NO. 58J6RDU8L9XIACT
CITRIC ACID2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
QUATERNIUM-15E40U03LEM0IACT
POLYSORBATE 207T1F30V5YHIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
QUATERNIUM-52588EQF3H1PIACT
GLYCERINPDC6A3C0OXIACT
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 4 · 212 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EXTENDED RELEASE / ORAL45 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM, AUGMENTED / TOPICAL0.1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SUBCUTANEOUS28 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / SUBLINGUAL24 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / RESPIRATORY (INHALATION)8 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACIDCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 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
0c76d9f5-4a95-47ec-92b3-9bff0100478c0c662992-3c83-482a-9634-4672eb9d1eab2011-06-30WarningsExact identifier
spl id: 0c76d9f5-4a95-47ec-92b3-9bff0100478c
spl set id: 0c662992-3c83-482a-9634-4672eb9d1eab

Reported adverse events (FAERS/openFDA)#

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