NDC 57337-100 Oatmeal Skin Relief Calming . 8oz

Dimethicone

NDC Product Code 57337-100

NDC Code: 57337-100

Proprietary Name: Oatmeal Skin Relief Calming . 8oz Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Dimethicone Additional informationCallout TooltipWhat 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.


Code Structure
  • 57337 - Rejoice International Inc.
    • 57337-100 - Oatmeal Skin Relief Calming .

NDC 57337-100-01

Package Description: 227 g in 1 BOTTLE

NDC Product Information

Oatmeal Skin Relief Calming . 8oz with NDC 57337-100 is a a human over the counter drug product labeled by Rejoice International Inc.. The generic name of Oatmeal Skin Relief Calming . 8oz is dimethicone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Rejoice International Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Oatmeal Skin Relief Calming . 8oz Active Ingredient(s)

Additional informationCallout TooltipWhat 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 3 g/227g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LAURETH-7 (UNII: Z95S6G8201)
  • MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • CETYL STEARATE (UNII: 06RI5UQA7L)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • WATER (UNII: 059QF0KO0R)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • DISTEARYLDIMONIUM (UNII: 251IW5I21C)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rejoice International Inc.
Labeler Code: 57337
FDA Application Number: part347 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-07-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Oatmeal Skin Relief Calming . 8oz Product Label Images

Oatmeal Skin Relief Calming . 8oz 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

Otc - Active Ingredient

Active IngredientDimethicone 1.3%

Otc - Purpose

PurposeSkin protectant

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

UseHelp prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings

Warnings For external use only.When using this product avoid contact with eyes. In case of eye contact, flush with water.Do not use onDeep or puncture wounds

Animal bites

Serious burns
Stop use and ask a doctor if conditions worsens. Symptoms last more than 7 days or clear up and occur again within a few days.

Dosage & Administration

Directions apply liberally as often as needed.

Other Safety Information

Other Information store at room temperature.

Inactive Ingredient

Inactive IngredientsWater, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propylene Glycol, Glycerin, Stearyl Alcohol, PEG-100 Stearate, Polyacrylamide, DMDM Hydrantoin, Isopropyl Myristate, Fragrance, C13-14 Isoparaffin, Laureth-7, Avena Sativa (Oat) Kernel Extract, Disodium EDTA, Methylparaben, Propylparaben

* Please review the disclaimer below.

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