Bedside Care: Package Insert / Prescribing Information - Drugs.com

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# Bedside Care

Package insert / prescribing information
Generic name: benzethonium chloride
Dosage form: topical liquid
Drug class: Antiseptic and germicides

Medically reviewed by Drugs.com. Last updated on Jan 24, 2022.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

For Full-Body Bathing And Perineal Clean-Up

Drug Facts

Active ingredient

Benzethonium Chloride 0.1%

Purpose

Antiseptic

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

Warnings

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

Stop using this product if:

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

For external use only.

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

Directions Cleanse the affected area according to protocol.

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

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)

BEDSIDE-CARE benzethonium chloride shampoo

Product Information
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC:11701-053
Route of Administration | TOPICAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
BENZETHONIUM CHLORIDE (BENZETHONIUM) | BENZETHONIUM CHLORIDE | 100 mg in 100 mL

Inactive Ingredients
Ingredient Name | Strength
CITRIC ACID MONOHYDRATE |
EDETATE SODIUM |
QUATERNIUM-15 |
GLYCERIN |
QUATERNIUM-52 |
POLYSORBATE 20 |
COCAMIDOPROPYL BETAINE |
SODIUM LAUROAMPHOACETATE |
WATER |

Packaging
# | Item Code | Package Description
1 | NDC:11701-053-04 | 118 mL in 1 BOTTLE, SPRAY
2 | NDC:11701-053-05 | 237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
OTC monograph not final | part333E | 06/15/2009 |

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name | Address | ID/FEI | Operations
Coloplast Manufacturing US, LLC |  | 110326675 | MANUFACTURE(11701-053)

Coloplast Manufacturing US, LLC

## More about Bedside Care (benzethonium chloride topical)

- Side effects
- Dosage information
- Drug class: antiseptic and germicides

Medical Disclaimer