NDC 68437-013 Diabecare Grisi Diabetics

Dimethicone

NDC Product Code 68437-013

NDC Code: 68437-013

Proprietary Name: Diabecare Grisi Diabetics 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: 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.

NDC Code Structure

  • 68437 - Grisi Hnos, S.a De C.v
    • 68437-013 - Diabecare Grisi Diabetics

NDC 68437-013-12

Package Description: 350 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Diabecare Grisi Diabetics with NDC 68437-013 is a a human over the counter drug product labeled by Grisi Hnos, S.a De C.v. The generic name of Diabecare Grisi Diabetics is dimethicone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Grisi Hnos, S.a De C.v

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 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.

Diabecare Grisi Diabetics 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 1.2 g/100mL

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.

  • NIACINAMIDE (UNII: 25X51I8RD4)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • PEG-75 STEARATE (UNII: OT38R0N74H)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CETETH-20 (UNII: I835H2IHHX)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DECYLENE GLYCOL (UNII: S57M60MI88)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Grisi Hnos, S.a De C.v
Labeler Code: 68437
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: 07-08-2019 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.

Diabecare Grisi Diabetics Product Label Images

Diabecare Grisi Diabetics 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 Ingredients/Ingredientes Activos

Dimethicone/Dimeticona 1.2%

Purpose/Utilidad

Skin protectant/Protector de piel

Uses/Usos

■ Temporarily protects and helps relieve chafed or cracked skin/Protege temporalmente y ayuda a aliviar la piel irritada o agrietada■ Helps protect from the drying effects of wind and cold weather / Ayuda a proteger de la resequedad causada por el viento y el clima frío

Warnings/Precauciones

■ For external use only / Sólo para uso externo

Do Not Use On/No Usar En

■ Animal bites / Picaduras de animales ■ Deep or puncture wounds / Heridas profundas o punzantes ■ Serious burns /Quemaduras graves

When Using This Product/Cuando Use Este Producto

■ Avoid contact with eyes/Evite el contacto con los ojos

Stop Use And Ask A Doctor If / Suspenda Su Uso Y Consulte A Su Médico Si

■ Condition worsens / La condición empeora■ Symptoms last more than 7 days or clear up and occur again within a few days/Los síntomas persisten por más de 7 días o mejoran y vuelven a aparecer a los pocos días

Keep Out Of Reach Of Children.

Manténgase fuera del alcance de los niños

Directions/Modo De Uso

■ Apply generously to affected area as needed/Aplique generosamente sobre el area afectada según sea necesario

Inactive Ingredients/Ingredientes Inactivos

Water, Niacinamide, Cetearyl Alcohol, Sorbitan Stearate, Shea Butter, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Glyceryl Stearate, Avocado Oil, Glycerin, PEG-75 Stearate, Ceteth-20, Steareth-20, Beeswax, Phenoxyethanol, Decylene Glycol, Caprylyl Glycol, Tetrasodium EDTA, BHT

* Please review the disclaimer below.

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