NDC 63517-131 Incontinence Care Wipe

Dimethicone

NDC Product Code 63517-131

NDC 63517-131-21

Package Description: 3 PACKAGE in 1 CARTON > 20 g in 1 PACKAGE

NDC 63517-131-22

Package Description: 3 POUCH in 1 PACKET > 1 PATCH in 1 POUCH > 52.93 g in 1 PATCH

NDC Product Information

Incontinence Care Wipe with NDC 63517-131 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Incontinence Care Wipe is dimethicone. The product's dosage form is swab and is administered via topical form.

Labeler Name: Cardinal Health

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug 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.

Incontinence Care Wipe Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIMETHICONE 32 mg/g
  • DIMETHICONE 32 mg/g

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.
  • 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.

Labeler Name: Cardinal Health
Labeler Code: 63517
FDA Application Number: part347 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 08-21-2015 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Incontinence Care Wipe Product Label Images

Incontinence Care Wipe 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

Active Ingredient

Dimethicone 3.2%

Purpose

Skin Protectant

Uses:

Helps treat and prevent diaper rash. Protects chafed skin associated with diaper rash and helps from wetness. Temporarily protects and helps relieve chapped or cracked skin.

Warnings:

  • ​For external use only.​Avoid contact with the eyes

Keep Out Of Reach Of Children

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

Do Not Use:

  • On deep or puncture woundsAnimal bitesSerious burns

Directions:

  • Tear open pouch and remove wipesThoroughly cleanse soiled area, using one wipe at a timeUse as often as necessaryDispose of cloths in a waste receptacleDo not flush​Heating Instructions:Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer.
  • Wipes should be warmed:in a single warming session at temperatures not exceeding 52
  • 0​C (125
  • ​0​F) and
  • For a maximum of 4 days.Discard wipes that have been:Exposed to warming temperatures exceeding 52
  • 0C (125
  • 0F); or
  • Stored longer than 4 days within the warmer; orBeen warmed, allowed to cool, and then re-warmed.

Other Information:

  • When not in a warmer, store between 15-30
  • ​0​C (59-86
  • ​0​F)

Inactive Ingredients:

Aqua, Glycerin, Cetearyl Alcohol, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Xanthan Gum

* Please review the disclaimer below.

Previous Code
63517-131
Next Code
63517-132