Label: ACNE ADVANCED TREATMENT SYSTEM- salicylic acid kit

  • NDC Code(s): 15751-3000-3, 15751-3010-5, 15751-3020-2, 15751-3030-2
  • Packager: Eminence Organic Skin Care Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 2, 2023

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

  • Drug Facts

  • Active ingredient

    Salicylic Acid 1%

    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 contact Poison Control Center right away.

  • Direcitons

    • Use 1 to 3 times daily.
    • Pump a small amount of product to transform the liquid into a lightweight foam. Apply to skin and massage gently with fingertips in a circular motion covering the face and neck. Rinse thoroughly and pat dry.
    • Because excessive drying of the skin may occur, strar 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.

  • 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 Glyceri], Decyl Glucoside, Sodium Cocoyl Glutamate, Citrus Grandis (Grapefruit) Peel Oil, Metha Spicata (Spearmint) Leaf Oil, Caprylyl Glycol, Tocopherol (Vitamin E), Panthenol (Provitamin B5), Thymus Vulgans (Thyme) Extract, Cinnamomum Zeylanicum (Cinnamon) Bark Extract, Ole Europaea (Olive) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Cocamidopropyl Dimethylamine, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Citrus Limon (Lemon) Peel Extract, Ethylhexylglycerin, Caffeine (from Green Tea), Sodium PCA, Arbutin, Biocomplex2 [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), Vegetable Glycerin. *Certified organic ingredient

  • 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.

  • SPL UNCLASSIFIED SECTION

  • 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

  • Drug Facts

  • Active ingredient

    Salicylic Acid 1%

    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 layer over the entire face and neck 1 to 3 times daily and leave on.
    • 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.

  • 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], Caprylic/Capric Triglyceride, Hamamelis Virginiana (Witch Hazel), Vegetable Glycerin, Propanediol, Citrus Grandis (Grapefruit) Peel Oil, Mentha Spicata (Spearmint) Leaf Oil, Sodium Acrylate, Nyphaea Caerulea (Blue Lotus) Flower Extract, Nelumbo Nucifera (Sacred Lotus) Flower Extract, Origanum Vulgare (Oregano) Leaf Extract, Thymus Vulgaris (Thyme) Extract, Cinnamomum Zeylanium (Cinnamon) Bark Extract, Olea Europaea (Olive) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Starch Octenylsuccinate, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Citrus Limon (Lemon) Peel Extract, Sodium Acrylolydimethyl Taurate Copolymer, Panthenol (Provitamin B5), Sodium Hydroxide, Isohexadecane, Niacinamide (Vitamin B3), Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Polysorbate 80, Lysolecithin, Caffeine (from Green Tea), Zinc Hyaluronate, Arbutin, Cocamidopropyl Dimethylamine, 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 Cleansing Foam 5oz (15751-3010-5)

    Label

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

    Label2.

  • Acne Advanced Clarifying Hydrator 1.2oz (15751-3030-2)

    Label4

  • Kit: Acne Advanced Treatment System (15751-3000-3)

    Kit

  • INGREDIENTS AND APPEARANCE
    ACNE ADVANCED TREATMENT SYSTEM 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-3000
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15751-3000-31 in 1 KIT09/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 150 mL
    Part 21 TUBE 60 mL
    Part 31 BOTTLE 35 mL
    Part 1 of 3
    ACNE ADVANCED CLEANSING 
    salicylic acid liquid
    Product Information
    Item Code (Source)NDC:15751-3010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 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)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    THYME (UNII: CW657OBU4N)  
    CINNAMON (UNII: 5S29HWU6QB)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSEMARY (UNII: IJ67X351P9)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    LEMON (UNII: 24RS0A988O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ARBUTIN (UNII: C5INA23HXF)  
    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:15751-3010-51 in 1 BOX
    1150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/01/2018
    Part 2 of 3
    ACNE ADVANCED CLARIFYING MASQUE 
    salicylic acid cream
    Product Information
    Item 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
    PEPPERMINT (UNII: V95R5KMY2B)  
    ALOE (UNII: V5VD430YW9)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G)  
    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 BOX
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/01/2018
    Part 3 of 3
    ACNE ADVANCED CLARIFYING HYDRATOR 
    salicylic acid cream
    Product Information
    Item Code (Source)NDC:15751-3030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 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)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    OREGANO (UNII: 0E5AT8T16U)  
    THYME (UNII: CW657OBU4N)  
    CINNAMON (UNII: 5S29HWU6QB)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSEMARY (UNII: IJ67X351P9)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    LEMON (UNII: 24RS0A988O)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    NIACIN (UNII: 2679MF687A)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ARBUTIN (UNII: C5INA23HXF)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    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:15751-3030-21 in 1 BOX
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/01/2018
    Labeler - Eminence Organic Skin Care Ltd. (205753317)