NDC 53329-074 Remedy Barrier Cream Cloths Fragrance Free
Dimethicone Cloth Topical

Product Information

Product Code53329-074
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.
Remedy Barrier Cream Cloths Fragrance Free
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Dimethicone
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormCloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Medline Industries, Lp
Labeler Code53329
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part347
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
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.
08-31-2016
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.
12-31-2022
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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 53329-074-76

Package Description: 8 APPLICATOR in 1 PACKAGE > 17 mL in 1 APPLICATOR

Product Details

Remedy Barrier Cream Cloths Fragrance Free is a human over the counter drug product labeled by Medline Industries, Lp. The generic name of Remedy Barrier Cream Cloths Fragrance Free is dimethicone. The product's dosage form is cloth and is administered via topical form.


What are Remedy Barrier Cream Cloths Fragrance Free Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SQUALANE (UNII: GW89575KF9)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • DULSE (UNII: 7832HOY4ZQ)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • CLOVE (UNII: K48IKT5321)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SOY PROTEIN (UNII: R44IWB3RN5)
  • ALLANTOIN (UNII: 344S277G0Z)
  • OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
  • C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
  • C14-22 ALCOHOLS (UNII: B1K89384RJ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
  • YEAST (UNII: 3NY3SM6B8U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • UREA (UNII: 8W8T17847W)
  • 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CORN OIL (UNII: 8470G57WFM)
  • VANILLA (UNII: Q74T35078H)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SQUALANE (UNII: GW89575KF9)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • DULSE (UNII: 7832HOY4ZQ)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • CLOVE (UNII: K48IKT5321)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SOY PROTEIN (UNII: R44IWB3RN5)
  • ALLANTOIN (UNII: 344S277G0Z)
  • OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
  • C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
  • C14-22 ALCOHOLS (UNII: B1K89384RJ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
  • YEAST (UNII: 3NY3SM6B8U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • UREA (UNII: 8W8T17847W)
  • 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CORN OIL (UNII: 8470G57WFM)
  • VANILLA (UNII: Q74T35078H)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Remedy Barrier Cream Cloths Fragrance Free Labeling and Warnings

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.

Table of Contents



Active Ingredient



Dimethicone 3.6%


Purpose



Skin Protectant


Uses



  • Helps protect from minor skin irritations associated with perineal dermatitis
  • temporarily protects and helps relieve chapped or cracked skin
  • Helps protect from the drying effects of wind and cold weather

Do Not Use



on

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product



do not get into eyes


Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Open package as designated
  • Remove fresh cloths and thoroughly cleanse soiled area as needed
  • Dispose of cloths in waste receptacle, do not flush in toilet
  • Single Patient Use only

Other Information



  • Protect from freezing, avoid excessive heat
  • Keep label tightly sealed
  • Do Not Flush
  • Cloth: made of Rayon/Polyester

Inactive Ingredients



Water, Glycerin, Squalane, Glycine Soja (Soybean) Oil, Algae Extract, Camellia Sinensis (Green Tea) Extract, Eugenia Caryophyllus (Clove) Flower Extract, Butyrospermum Parkii (Shea Butter) Extract, Lecithin, Hydrolyzed Soy Protein, Allantoin, Phospholipids, C12-20 Alkyl Clucoside, C14-22 Alcohols, Cetyl Alcohol, Disodium Cocoamphodiacetate, Caprylic/Capric Triglyceride, Citric Acid, Cocoglucoside, Coconut Alcohol, Ethylene Brassylate, Ethylexylglycerin, Butylene Glycol, Isopropyl Myristate, Methyldihydrojasmonate, Yeast Ferment Extract, Phenoxyethanol, Tocopheryl Acetate, Urea, 7- Dehydrocholesterol, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Vanilla Planifolia Fruit Extract


* Please review the disclaimer below.