Bedside-care Shampoo
FDA Label NDC 11701-053

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coloplast Corp for the product Bedside-care (NDC 11701-053). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

For Full-Body Bathing And Perineal Clean-Up

Drug Facts

For external use only.

Otc - Active Ingredient

Active ingredient

Benzethonium Chloride 0.1%

Otc - Purpose

Purpose

Antiseptic

Indications & Usage

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

Warnings

Warnings

Otc - When Using

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

Otc - Stop Use

Stop using this product if:

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions Cleanse the affected area according to protocol.

Inactive Ingredient

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)

Principal Display Panel (118 mL Bottle Label)

Principal Display Panel (118 mL Bottle Label)

* Please review the disclaimer below.