Acne Advanced Treatment System Kit
FDA Label NDC 15751-3000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eminence Organic Skin Care Ltd. for the product Acne Advanced Treatment System (NDC 15751-3000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, when using this product, keep out of reach of children., direcitons, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Salicylic Acid 1%

Salicylic Acid 0.5%

Salicylic Acid 1%

Purpose

Acne Treatment

Acne Treatment

Acne Treatment

Use

  • For the treatment of acne.
    • For the treatment of acne.
      • For the treatment of acne.

Warnings

For external use only

For external use only

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.
    • 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.
      • 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.

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

If swallowed, get medical help or contaact 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.
    • 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.
      • 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.

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.

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

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

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 (15751 3010 5 Acne Advanced Cleansing Foam 5oz Foaming Bottle Silkscreen1)

Label (15751 3010 5 Acne Advanced Cleansing Foam 5oz Foaming Bottle Silkscreen1)

Acne Advanced Clarifying Masque 2Oz (15751-3020-2)

Label2. (15751 3020 2 Advanced Acne Treatment Masque 2oz Tube Silkscreen1)

Label2. (15751 3020 2 Advanced Acne Treatment Masque 2oz Tube Silkscreen1)

Acne Advanced Clarifying Hydrator 1.2Oz (15751-3030-2)

Label4 (15751 3030 2 Acne Advanced Clarifying Hydrator 1.2oz Silkscreen1)

Label4 (15751 3030 2 Acne Advanced Clarifying Hydrator 1.2oz Silkscreen1)

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

Kit (Kit)

Kit (Kit)

* Please review the disclaimer below.