NDC 11701-052 Bedside-care Foam (alcohol Free)

Product Information

What is NDC 11701-052?

The NDC code 11701-052 is assigned by the FDA to the product Bedside-care Foam (alcohol Free) which is product labeled by Coloplast Manufacturing Us, Llc. The product's dosage form is and is administered via form. The product is distributed in 2 packages with assigned NDC codes 11701-052-04 118 ml in 1 bottle, spray , 11701-052-05 237 ml in 1 bottle, spray . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code11701-052
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Bedside-care Foam (alcohol Free)
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Coloplast Manufacturing Us, Llc
Labeler Code11701
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-15-2009
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2019
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Bedside-care Foam (alcohol Free)?


Product Packages

NDC Code 11701-052-04

Package Description: 118 mL in 1 BOTTLE, SPRAY

NDC Code 11701-052-05

Package Description: 237 mL in 1 BOTTLE, SPRAY

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Bedside-care Foam (alcohol Free) Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Bedside-care Foam (alcohol Free) Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Bedside-care Foam (alcohol Free) Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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 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 the 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, fragrance, tetrasodium EDTA, green 5

Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Cleansing: apply to the affected perineal 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 #7145 Made in the U.S.A.

G7-1276


Principal Display Panel - 118 Ml Bottle Label



NDC 11701-052-04

Bedside-Care® 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)


* Please review the disclaimer below.