NDC 76348-580 Pediadermics Eczema 3

Colloidal Oatmeal, Dimethicone

NDC Product Code 76348-580

NDC CODE: 76348-580

Proprietary Name: Pediadermics Eczema 3 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.

Non-Proprietary Name: Colloidal Oatmeal, Dimethicone 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 76348 - Renu Laboratories, Inc.

NDC 76348-580-06

Package Description: 168 g in 1 TUBE

NDC Product Information

Pediadermics Eczema 3 with NDC 76348-580 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of Pediadermics Eczema 3 is colloidal oatmeal, dimethicone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Renu Laboratories, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Pediadermics Eczema 3 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 3.36 g/168g
  • OATMEAL .168 g/168g

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.

  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • CERAMIDE 1 (UNII: 5THT33P7X7)
  • JOJOBA OIL (UNII: 724GKU717M)
  • RICE BRAN (UNII: R60QEP13IC)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • WATER (UNII: 059QF0KO0R)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CERAMIDE NP (UNII: 4370DF050B)
  • POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HEXANEDIOL (UNII: ZIA319275I)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • OAT (UNII: Z6J799EAJK)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
  • CANDELILLA WAX (UNII: WL0328HX19)

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: Renu Laboratories, Inc.
Labeler Code: 76348
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: 10-01-2020 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: 12-31-2021 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.

Pediadermics Eczema 3 Product Label Images

Pediadermics Eczema 3 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 IngredientsColloidal oatmeal 0.1%Dimethicone 2%

Otc - Purpose

PurposeSkin protectantSkin protectant

Indications & Usage

UsesTemporarily protects sensitive skin and helps relieve minor skin irritation due to eczema. Temporarily helps prevent and relieve chapped or cracked skin.

Warnings

WarningsFor external use only

Otc - When Using

  • When using this productDo not get into eyesDo not apply before bathing or showering

Otc - Stop Use

  • Stop use and ask a doctor ifCondition worsensSymptoms last more than 2 weeks or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • DirectionsFor best results, follow the rule of "3"Apply liberally to skin at least "3" times a dayApply within "3" minutes of bathingKeep a "3" location supply (Home, On-the-Go and School) !

Inactive Ingredient

Inactive Ingredients1,2 Hexanediol, Ascorbyl Palmitate, Bio-Saccharide 1, Candelilla / Jojoba / Rice bran, Polyglyceryl-3 Esters, Glyceryl Stearate, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetyl Alcohol, Cholesterol, Deionized Water, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Niacinamide, Ophiopogon Japonicus Root Extract, Maltodextrin, Phytosphingosine, Propanediol, Saccharide Isomerate, Sodium EDTA, Sodium Hyaluronate, Sodium PCA, Stearic Acid, Tocopherol, Xanthan Gum

Other Safety Information

Other informationStore at room temperature.

Otc - Questions

Questions?pediadermics@gmail.com

Statement Of Identity

Eczema 3skin barrier repair cream

* Please review the disclaimer below.