NDC 10056-410 Artistry Studio Rose All Day Anti Acne Toner Pore Refresher

Salicylic Acid

NDC Product Information

Artistry Studio Rose All Day Anti Acne Toner Pore Refresher with NDC 10056-410 is a a human over the counter drug product labeled by Access Business Group Llc. The generic name of Artistry Studio Rose All Day Anti Acne Toner Pore Refresher is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Access Business Group Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Artistry Studio Rose All Day Anti Acne Toner Pore Refresher 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 10 mg/mL

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)
  • ALCOHOL (UNII: 3K9958V90M)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ALLANTOIN (UNII: 344S277G0Z)
  • CETETH-20 (UNII: I835H2IHHX)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ICODEXTRIN (UNII: 2NX48Z0A9G)
  • ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • SYRINGA VULGARIS WHOLE (UNII: U49SHU1VCI)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
  • CHIA SEED OIL (UNII: MC2LH51BO7)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)
  • CERAMIDE NP (UNII: 4370DF050B)
  • .BETA.-SITOSTEROL (UNII: S347WMO6M4)
  • PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
  • EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
  • PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)

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.
  • 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: Access Business Group Llc
Labeler Code: 10056
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: 09-23-2020 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.

Artistry Studio Rose All Day Anti Acne Toner Pore Refresher Product Label Images

Artistry Studio Rose All Day Anti Acne Toner Pore Refresher 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

Salicylic Acid 1.0% (W/W)

Purpose

Acne Treatment

Use

  • For the treatment of acne.

Warnings

For external use only

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a doctor/health care practitioner.Apply to affected areas only

Do Not Use

On broken skin or apply to large areas of the bodyAvoid contact with eyes. If contact occurs, rinse thoroughly with water. Discontinue use if excessive skin irritation develops or increases. If irritation persists, consult a doctor/health care practitioner.

Directions

  • Cleanse the skin thoroughly before applying product. Cover the entire affected areas with a thin layer one to three times daily.Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor/health care practitioner.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water/aqua, alcohol denat., PEG-8, lactobacillus/punica granatum fruit ferment extract, sodium hydroxide, pentylene glycol, allantoin,


ceteth-20, dipotassium glycyrrhizate, disodium EDTA, PEG-60 almond glycerides, butylene glycol, glycerin, maltodextrin, aloe barbadensis leaf juice, dextrin, rosa damascena flower extract, leuconostoc/radish root ferment filtrate, lecithin, syringa vulgaris (lilac) extract, bisabolol, punica


granatum fruit extract, phenoxyethanol, rosa centifolia flower extract, salvia hispanica (chia) seed oil, chlorphenesin, red 4 (CI 14700), ceramide NP, beta-sitosterol, perilla ocymoides leaf extract, oenothera biennis (evening primrose) oil, perilla ocymoides seed oil, tocopherol, glycine soja


(soybean) oil, potassium sorbate, sodium benzoate, BHT, helianthus annuus (sunflower) seed oil.

* Please review the disclaimer below.