NDC 63517-126 Personal Cleansing With Dimethicone

Dimethicone

NDC Product Code 63517-126

NDC 63517-126-21

Package Description: 42 POUCH in 1 PACKET > 1 PATCH in 1 POUCH > 28.59 mL in 1 PATCH

NDC Product Information

Personal Cleansing With Dimethicone with NDC 63517-126 is a a human over the counter drug product labeled by Cardinal Health, Inc.. The generic name of Personal Cleansing With Dimethicone is dimethicone. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Cardinal Health, Inc.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It 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.

Personal Cleansing With Dimethicone 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/mL

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)
  • 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)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • 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.

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, Inc.
Labeler Code: 63517
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-15-2019 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: 12-31-2020 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.

Personal Cleansing With Dimethicone Product Label Images

Personal Cleansing With Dimethicone 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

  • Temporarily protects and helps relieve chapped or cracked skinhelps prevent perineal dermatitis protects minor skin irritation associated with perineal dermatitis

Warnings

For external use only

When Using This Product

  • Avoid direct contact with the eyes

Stop Use And Contact A Physician

  • If condition worsenssymptoms 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 Posion Control Center right away.Discontinue if irritation or redness developsGloves diminish sensitivity to heatClosely monitor heat level with infants, unresponsive or skin sensitive individuals

Do Not Use

  • On deep or puncture woundsAnimal bitesSerious burns

Directions

  • Pull back label and remove wipesThoroughly cleanse soiled area, using one wipe at a timeUse as often as necessaryDispose of cloths in a waste receptacleDo not flush Warming 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°C (125°F) and for a maximum of 200 hours. Discard wipes that have been:Exposed to warming temperatures exceeding 52°C (125°F); or Stored longer than 200 hours within the warmer; orBeen warmed, allowed to cool, and then re-warmed

Other Information

When not in a warmer, store between 15-30˚C (59-86˚F).

Inactive Ingredients

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

* Please review the disclaimer below.