NDC 60899-010 Seaweed Aqua Massage

Allantoin

NDC Product Code 60899-010

NDC 60899-010-01

Package Description: 300 g in 1 CARTON

NDC Product Information

Seaweed Aqua Massage with NDC 60899-010 is a a human over the counter drug product labeled by Amaros Co., Ltd.. The generic name of Seaweed Aqua Massage is allantoin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Amaros 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.

Seaweed Aqua Massage 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.

  • ALLANTOIN 1.5 g/300g

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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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: Amaros Co., Ltd.
Labeler Code: 60899
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: 09-01-2013 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Seaweed Aqua Massage Product Label Images

Seaweed Aqua Massage 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: Allantoin 0.5%

Inactive Ingredient

Inactive Ingredients: Water, Butylene Glycol, Sodium Hyaluronate, Cetyl Ethylhexanoate, Aloe Barbadensis Leaf Juice, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Fruit Oil, Cetearyl Alcohol, Sorbitan Olivate, Macadamia Ternifolia Seed Oil, Glyceryl Stearate, Betaine, PEG/PPG-17/6 Copolymer, Simondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, PEG-100 Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Chloride, Tocopheryl Acetate, Panthenol, Propolis Extract, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Algae Extract, Caprylyl Glycol, Caprylhydroxamic Acid, Beta-Glucan, Lecithin, Disodium EDTA, Ceramide 3, Fragrance.

Purpose

Purpose: Skin Protectant

Warnings

Warnings: 1. In case of having following symptoms after using this product, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Keep Out Of Reach Of Children

Keep out of reach of children: Keep out of reach of babies and children.

Indications And 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 washing face.

Dosage And Administration

Dosage and Administration: Apply a small amount of massage cream and rub it into skin, during rubbing the cream, on the skin surface appears droplets of water, which moisturizes and gives a cooling effect to skin. Make-up can be applied over the massage cream. The above product can be applied as night cream or a moisture pack (for 20-30min). There is no sticky or oily feeling after applying of this product, so you may not wash off face after massage procedure.

* Please review the disclaimer below.