NDC 68988-060 Plagentra Baby

Dimethicone

NDC Product Code 68988-060

NDC 68988-060-01

Package Description: 100 g in 1 CARTON

NDC Product Information

Plagentra Baby with NDC 68988-060 is a a human over the counter drug product labeled by C.a Pharm Co., Ltd.. The generic name of Plagentra Baby is dimethicone. The product's dosage form is cream and is administered via topical form.

Labeler Name: C.a Pharm Co., Ltd.

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.

Plagentra Baby 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 g/100g

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)

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: C.a Pharm Co., Ltd.
Labeler Code: 68988
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: 04-01-2014 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.

Plagentra Baby Product Label Images

Plagentra Baby 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

Active Ingredient: Dimethicone 1%

Inactive Ingredient

Inactive Ingredients:Water, Glycerin, Cyclopentasiloxane, Sorbitan Stearate, Cetyl Alcohol, Stearic Acid, Phytosqualane, Isohexadecane, Triethylhexanoin, Prunus Armeniaca (Apricot) Kernel Oil, Ulmus Davidiana Root Extract, Amaranthus Caudatus Seed Extract, Piper Methysticum Leaf/Root/Stem Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Portulaca Oleracea Extract, Paeonia Albiflora Root Extract, Cnidium Officinale Root Extract, Pueraria Thunbergiana Root Extract, Soluble Collagen, Aloe Barbadensis Leaf Juice, Hydrogenated Lecithin, Sodium Hyaluronate, Polysorbate 60, Tromethamine, Sorbitan Sesquioleate, Sucrose Cocoate, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Polymethacrylate, Carbomer, Caprylhydroxamic Acid, Tocopheryl Acetate, Disodium EDTA, Dipotassium Glycyrrhizate, Butylene Glycol, Panthenol, Xanthan Gum, Folic Acid, Ceramide 3, Cholesterol, Raffinose, Polyglutamic Acid, Phytosphingosine, Palmitoyl Pentapeptide-4, Fragrance

Purpose

Purpose: Skin Portectant

Warnings

Warnings:1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.2. Do not apply the product to wounds or skin with dermatitis such as eczema.3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.

Keep Out Of Reach Of Children

Keep out of reach of babies and children.

Indications & Usage

Indication and usage:1) Tighten the lid after using it.2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.3) Use it in the morning or evening after shower.

Dosage & Administration

Dosage and administration:Take appropriate amount to the entire face and body, gently massage and tapping until absorbed.

* Please review the disclaimer below.

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