NDC 73058-001 Jumiso No Pain No Gain Ac Cure Spot

Salicylic Acid

NDC Product Code 73058-001

NDC Code: 73058-001

Proprietary Name: Jumiso No Pain No Gain Ac Cure Spot 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: Salicylic Acid 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

  • 73058 - Hello Skin Co.,ltd.
    • 73058-001 - Jumiso No Pain No Gain Ac Cure Spot

NDC 73058-001-02

Package Description: 1 CONTAINER in 1 PACKAGE > 15 g in 1 CONTAINER (73058-001-01)

NDC Product Information

Jumiso No Pain No Gain Ac Cure Spot with NDC 73058-001 is a a human over the counter drug product labeled by Hello Skin Co.,ltd.. The generic name of Jumiso No Pain No Gain Ac Cure Spot is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Hello Skin 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.

Jumiso No Pain No Gain Ac Cure Spot 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.

  • SALICYLIC ACID .0015 g/15g

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)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LITHOSPERMUM ERYTHRORHIZON ROOT (UNII: 9I70D8O47I)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MACADAMIA OIL (UNII: 515610SU8C)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • BABASSU OIL (UNII: 8QSB4M5477)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • IRIS DOMESTICA ROOT (UNII: T2MU9QFA87)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • OCTANEDIOL (UNII: 806K32R50Z)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALLANTOIN (UNII: 344S277G0Z)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ALCOHOL (UNII: 3K9958V90M)
  • PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
  • COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9)
  • CITRUS MAXIMA SEED (UNII: 083X55C543)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • POLYGALIC ACID (UNII: XCC6WEA55L)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • ADENOSINE (UNII: K72T3FS567)
  • CERAMIDE NP (UNII: 4370DF050B)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • ROSEMARY (UNII: IJ67X351P9)
  • PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • CITRUS BERGAMIA LEAF (UNII: ZGS96VDV4T)
  • LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • CALCIUM PANTOTHENATE (UNII: 568ET80C3D)

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: Hello Skin Co.,ltd.
Labeler Code: 73058
FDA Application Number: part333D 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: 04-18-2019 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.

Jumiso No Pain No Gain Ac Cure Spot Product Label Images

Jumiso No Pain No Gain Ac Cure Spot 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

Salicylic Acid 0.01%

Otc - Purpose

Acne Treatment

Indications & Usage

For the treatment of Acne

Dosage & Administration

Following facial cleansing, dispense a small amount onto a clean finger and apply on the desired area, evenly massaging contents into the skin to aid absorption.

Warnings

For external use only


When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid contact with eyes. If contact occurs, flush thoroughly with water.


People with allergy to aspirin will react poorly to the Salicylic Acid.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive Ingredient

Water, Butylene Glycol, Silica, Niacinamide, Glycerin, Lithospermum Erythrorhizon Root Oil, Caprylic/Capric Triglyceride, Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Argania Spinosa Kernel Oil, Sodium Hyaluronate, Orbignya Oleifera Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Cetearyl Alcohol, Belamcanda Chinensis Root Extract, Sorbitan Monostearate, Propylene Glycol, Octanediol, Stearic acid, Bacopa Monniera Extract, Carbomer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Triethanolamine, 1,2-Hexandiol, Ethylhexylglycerin, Allantoin, Dimethyl Sulfone, Alcohol, Phellodendron Amurense Bark Extract, Coptis Chinensis Root Extract, Aloe Barbadensis Leaf Extract, Luffa Cylindrica Fruit Extract, Citrus grandis (grapefruit) seed extract, Tocopheryl Acetate, Centella Asiatica Extract, Dipotassium Glycyrrhizate, Polyglutamic acid, Tocopherol, Hydrogenated Lecithin, Adenosine, Ceramide NP, Disodium EDTA, Camellia Sinensis Leaf Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Maltodextrin / Sodium Starch Octenylsuccinate, Rosmarinus Officinalis (Rosemary) Leaf Extract, PEG-10 Rapeseed sterol, Hydroxyethylcellulose, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosa Centifolia Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Calcium Pantothenate, Artemisia princeps extract, Dipropylene Glycol, Methionine, Serine, Histidine, Hydroxyethylethylcelluose, Chamomilla Recutita (matricaria) Flower Extract, Sodium Ascorbyl Phosphate, Glyceryl Stearate, Glycereth-20, Portulaca Oleracea Extract, Dryopteris Filix-Mas Root Extract, Phenoxyethanol, Pyridoxine HCl

* Please review the disclaimer below.

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