Label: THERAPEUTIC HYDROGEL- salicylic acid cream

  • NDC Code(s): 78863-1090-1
  • Packager: Noon Aesthetics M.R. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 23, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active Ingredients

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Use for the treatment of acne.

  • 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.

    • Keep out of reach of children.

    If swallowed, get help or contact a Poison Control Center right away.

  • Directions

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

  • Inactive Ingredients

    Aqua, Lactic Acid, Propanediol, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polyacrylate Crosspolymer-6, Isononyl Isononanoate, Ethylhexyl Stearate, Citronellyl Methylcrotonate, Polysorbate 20, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Wheat Straw Glycosides, Cetearyl Alcohol, Cyclopentasiloxane ,Dimethicone, Parfum, Caprylyl Glycol, T-Butyl Alcohol, Sodium Phytate, Xhantan Gum, Sodium Hydroxide

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    Visit www. noonaesthetics.com or call Toll Free 1-833-666-6246

  • SPL UNCLASSIFIED SECTION

    Developed and Dist. by
    NOON Aesthetics
    18th Ahavat Zion
    TLV, 62153.

  • PRINCIPAL DISPLAY PANEL - 50 gr Bottle Carton

    NOON™

    Therapeutic
    Hydrogel
    with DermShield™

    A Potent Skin Balancer
    and Moisturizer
    Intensive Treatment for
    Oily / Combination Skin

    Lactic Acid 10%
    Salicyclic Acid 2 %
    pH 3.5

    PARACEUTICAL

    50 gr / 1.76 Oz ℮

    PRINCIPAL DISPLAY PANEL - 50 gr Bottle Carton
  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC HYDROGEL 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78863-1090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Propanediol (UNII: 5965N8W85T)  
    Water (UNII: 059QF0KO0R)  
    Phytate Sodium (UNII: 88496G1ERL)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Strontium Chloride Hexahydrate (UNII: O09USB7Z44)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.S) (UNII: Q7UI015FF9)  
    Tert-Butyl Alcohol (UNII: MD83SFE959)  
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Cetearyl Wheat Straw Glycosides (UNII: B44PS4T8IN)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Citronellyl Methylcrotonate (UNII: K61O222P3D)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78863-1090-11 in 1 CARTON05/01/2020
    150 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00605/01/2020
    Labeler - Noon Aesthetics M.R. Ltd (600185560)
    Establishment
    NameAddressID/FEIBusiness Operations
    NOON Aesthetics M.R Ltd600185560MANUFACTURE(78863-1090)
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