Label: ARTISTRY STUDIO DONE WITH ZIT ACNE TREATMENT CLEARING GEL- salicylic acid gel

  • NDC Code(s): 10056-045-00
  • Packager: Access Business Group LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Salicylic Acid 2.0% (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.

  • SPL UNCLASSIFIED SECTION

    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 tolarge areas of the body

    Avoid 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/eau, alcohol denat., PEG-8, hydroxyethylcellulose, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, sodium hydroxide, disodium EDTA, allantoin, PEG-60 almond glycerides, fragrance/parfum, butylene glycol, pentylene glycol, caffeine, isononyl isononanoate, lecithin, maltodextrin, phenoxyethanol, salvia hispanica seed extract, mangifera indica (mango) fruit extract, syringa vulgaris (lilac) extract, sodium citrate, ceramide NP, citric acid, potassium sorbate, sodium benzoate, beta-sitosterol, chlorphenesin, orthosiphon stamineus extract, xanthan gum, tocopherol, limonene, citral, linalool

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ARTISTRY STUDIO DONE WITH ZIT ACNE TREATMENT CLEARING GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHIA SEED (UNII: NU0OLX06F8)  
    MANGO (UNII: I629I3NR86)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10056-045-001 in 1 CARTON06/23/2021
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00606/23/2021
    Labeler - Access Business Group LLC (839830713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Access Business Group LLC839830713manufacture(10056-045)