NDC 80972-0002 Aquato Intensive Calminglotion

Adenosine

NDC Product Code 80972-0002

NDC 80972-0002-1

Package Description: 160 mL in 1 TUBE

NDC Product Information

Aquato Intensive Calminglotion with NDC 80972-0002 is a a human over the counter drug product labeled by Natural Story Co.,ltd.. The generic name of Aquato Intensive Calminglotion is adenosine. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Natural Story Co.,ltd.

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.

Aquato Intensive Calminglotion 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.

  • UNDARIA PINNATIFIDA .0005 g/100mL
  • HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE .001 g/100mL
  • 50000 MW)

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)

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: Natural Story Co.,ltd.
Labeler Code: 80972
Marketing Category: UNAPPROVED DRUG OTHER - 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: 12-25-2020 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.

Aquato Intensive Calminglotion Product Label Images

Aquato Intensive Calminglotion 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

Adenosne

Inactive Ingredient

WATER

GLYCERIN

ETHYLHEXYL STEARATE

1,2-HEXANEDIOL

CETEARYL ALCOHOL

POLYGLYCERYL-3 DISTEARATE

GLYCERYL STEARATE CITRATE

PHENYL TRIMETHICONE

WATER

DIPROPYLENE GLYCOL

GLYCERIN

LAMINARIA JAPONICA EXTRACT

ECLIPTA PROSTRATA LEAF EXTRACT

1,2-HEXANEDIOL

FRUCTOOLIGOSACCHARIDES

BETA-GLUCAN

HYDROGENATED LECITHIN

HYDROLYZED HYALURONIC ACID

METHYL TRIMETHICONE

PROPANEDIOL

WATER

GLYCERIN

1,2-HEXANEDIOL

BETA-GLUCAN

WATER

BUTYLENE GLYCOL

1,2-HEXANEDIOL

ULMUS DAVIDIANA ROOT EXTRACT

AMARANTHUS CAUDATUS SEED EXTRACT

GLYCERYL STEARATE

GLYCERIN

BUTYLENE GLYCOL

WATER

HYDROGENATED LECITHIN

FICUS CARICA (FIG) FRUIT EXTRACT

CENTELLA ASIATICA EXTRACT

1,2-HEXANEDIOL

CERAMIDE NP

SODIUM STEAROYL GLUTAMATE

ARGININE

CARBOMER

BETAINE

BEHENYL ALCOHOL

CETEARYL ALCOHOL

HYDROGENATED LECITHIN

GLYCERYL STEARATE SE

CHOLESTEROL

CERAMIDE NP

ETHYLHEXYLGLYCERIN

TOCOPHEROL

CARBOMER

WATER

1,2-HEXANEDIOL

GLYCOSAMINOGLYCANS

WATER

1,2-HEXANEDIOL

UNDARIA PINNATIFIDA EXTRACT

DISODIUM EDTA

Otc - Purpose

Special skincare for dry and sensitive skin with abundant moisture and sea algae extract

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Apply proper amount to the skin

Warnings

Keep out of reach of children.Store in a cool, dry place and avoid direct sunlight.Do not inhale or drink it.Discontinue use if skin allergy or discomfort occurs.

Dosage & Administration

For external use only

* Please review the disclaimer below.