Label: ACNE ADVANCED CLARIFYING MASQUE- salicylic acid cream

  • NDC Code(s): 15751-3020-2, 15751-3020-4, 15751-3020-6
  • Packager: Eminence Organic Skin Care Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 12, 2023

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  • Drug Facts

  • Active ingredient

    Salicylic Acid 0.5%

    Purpose

    Acne Treatment

  • Use

    • For the treatment of acne.
  • Warnings

    For external use only

    When using this product

    • Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. if irritation occurs, use only one product at a time.
    • Avoid eye area. In case of eye contact, flush gently and thoroughly with water.

    Keep out of reach of children.

    If swallowed, get medical help or contaact Poison Control Center right away.

  • Direcitons

    • Cleanse skin thoroughly before applying this product 
    • Apply a small amount evenly over the entire face or as a spot treatment as desired.
    • Allow to dry for 5 to 10 minutes. 
    • Rinse thoroughly with lukewarm water and use a face cloth if desired.
    • Use weekly as a masque, or as a spot treatment up to 3 times per day. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 ot 3 times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Other information

    Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed. Do not use if seal under cap is broken or missing.

  • Inactive ingredients

    Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix Alba (Willow) Bark Extract, Rosa Canina (Rosehip) Seed Extract, Citrus Paradisi (Grapefruit) Peel Extract, Symphytum Officinale (Comfrey) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glycerin], Kaolin Clay, Red Kaolin Clay, Vegetable Glycerin, Glycine Soja Soybean) Oil, Benzyl Alcohol, Helianthus Annuus (Sunflower Seed) Oil, Sorbic Acid, Polyacrylate 13, Citrus Grandis (Grapefruit) Peel Oil, Metha Spicata (Spearmint) Leaf Oil, Polysobutene, Cocamidopropyl Dimethylamine, Sulfur, Ocimum Basillicum (Basil) Oil, Lavandula Angustifolia (Lavender) Flower Extract, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Montmorillonite Caly, Sodium PCA, Polysorbate 20, Eucalyptus Globulus (Eucalyptus) Oil, Retinyl Palmitate (Vitamin A), Usnea Barbata (Lichen) Extract, Biocomplex2 [Euterpe Oleracea (Acai), [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)

    *Certified organic ingredient

  • Acne Advanced Clarifying Masque 2oz Box (15751-3020-2)

    Label2

  • Acne Advanced Clarifying Masque 2oz Bottle (15751-3020-2)

    Bottle

  • Acne Advanced Clarifying Masque 4oz (15751-3020-4)

    Label3

  • Acne Advanced Clarifying Masque 0.10oz (15751-3020-6)

    Label02

  • INGREDIENTS AND APPEARANCE
    ACNE ADVANCED CLARIFYING MASQUE 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-3020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BETA VULGARIS (UNII: 4G174V5051)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    SULFUR (UNII: 70FD1KFU70)  
    BASIL OIL (UNII: Z129UMU8LE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MONTMORILLONITE (UNII: A585MN1H2L)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ACAI (UNII: 46AM2VJ0AW)  
    CARROT (UNII: L56Z1JK48B)  
    COCONUT (UNII: 3RT3536DHY)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15751-3020-21 in 1 BOX09/01/2018
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:15751-3020-4120 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2018
    3NDC:15751-3020-63 mL in 1 PACKET; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/01/2018
    Labeler - Eminence Organic Skin Care Ltd. (205753317)
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