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

NDC Product Code 11701-052

NDC CODE: 11701-052

Proprietary Name: Bedside-care Foam (alcohol Free) 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.

NDC Code Structure

NDC 11701-052-04

Package Description: 118 mL in 1 BOTTLE, SPRAY

NDC 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.

NDC Product Information

Bedside-care Foam (alcohol Free) with NDC 11701-052 is a product labeled by Coloplast Manufacturing Us, Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1049093 and 1052610.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • QUATERNIUM-15 (UNII: E40U03LEM0)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • QUATERNIUM-52 (UNII: 588EQF3H1P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Coloplast Manufacturing Us, Llc
Labeler Code: 11701
Start Marketing Date: 06-15-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 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.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Bedside-care Foam (alcohol Free) Product Label Images

Bedside-care Foam (alcohol Free) Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

For Full-Body Bathing And Perineal Clean-Up

Drug Facts

For external use only.

Otc - Active Ingredient

Active ingredientBenzethonium Chloride 0.1%

Otc - Purpose

PurposeAntiseptic

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 developif 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 5Protocol: 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, DenmarkDistributed 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

* Please review the disclaimer below.