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| Product NDC Code | 15751-3000 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne advanced treatment system |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 248684, 417424, 1038982, 2055315 |
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| Application Number | M006 | ||||
| Labeler Name | Eminence Organic Skin Care Ltd. | ||||
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 1% Purpose Acne Treatment
Active ingredient Salicylic Acid 0.5% Purpose Acne Treatment
Active ingredient Salicylic Acid 1% Purpose Acne Treatment
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
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.
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
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
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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For the treatment of acne.
Use For the treatment of acne.
Use For the treatment of acne.
Purpose
Information about the drug product’s indications for use.Purpose Acne Treatment
Purpose Acne Treatment
Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.Acne Advanced Treatment System SALICYLIC ACID Acne Advanced Cleansing SALICYLIC ACID ALOE CUCUMBER ROSA MOSCHATA OIL GRAPEFRUIT SYMPHYTUM UPLANDICUM LEAF PEPPERMINT CALENDULA OFFICINALIS FLOWER BETA VULGARIS GLYCERIN DECYL GLUCOSIDE SODIUM COCOYL GLUTAMATE SPEARMINT CAPRYLYL GLYCOL TOCOPHEROL DEXPANTHENOL THYME CINNAMON OLIVE OIL ROSEMARY COCAMIDOPROPYL DIMETHYLAMINE GOLDENSEAL LEMON ETHYLHEXYLGLYCERIN GREEN TEA LEAF SODIUM PYRROLIDONE CARBOXYLATE ARBUTIN ACAI CARROT COCONUT STARCH, TAPIOCA THIOCTIC ACID UBIDECARENONE SALICYLIC ACID SALICYLIC ACID Acne Advanced Clarifying Masque SALICYLIC ACID PEPPERMINT ALOE CUCUMBER ROSA MOSCHATA OIL GRAPEFRUIT SYMPHYTUM UPLANDICUM LEAF CALENDULA OFFICINALIS FLOWER BETA VULGARIS GLYCERIN SOYBEAN OIL BENZYL ALCOHOL SUNFLOWER OIL SORBIC ACID SODIUM POLYACRYLATE (2500000 MW) SPEARMINT COCAMIDOPROPYL DIMETHYLAMINE SULFUR BASIL OIL XANTHAN GUM MONTMORILLONITE SODIUM PYRROLIDONE CARBOXYLATE POLYSORBATE 20 EUCALYPTUS OIL VITAMIN A PALMITATE ACAI CARROT COCONUT STARCH, TAPIOCA THIOCTIC ACID UBIDECARENONE SALICYLIC ACID SALICYLIC ACID Acne Advanced Clarifying Hydrator SALICYLIC ACID ALOE CUCUMBER ROSA MOSCHATA OIL GRAPEFRUIT SYMPHYTUM UPLANDICUM LEAF PEPPERMINT CALENDULA OFFICINALIS FLOWER BETA VULGARIS GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PROPANEDIOL CITRUS MAXIMA FRUIT RIND OIL SPEARMINT SODIUM ACRYLATE OREGANO THYME CINNAMON OLIVE OIL ROSEMARY GOLDENSEAL LEMON DEXPANTHENOL SODIUM HYDROXIDE ISOHEXADECANE NIACIN ALLANTOIN POLYSORBATE 80 LYSOPHOSPHATIDYLCHOLINE, SOYBEAN GREEN TEA LEAF ARBUTIN COCAMIDOPROPYL DIMETHYLAMINE SOYBEAN OIL BENZYL ALCOHOL SUNFLOWER OIL SORBIC ACID SODIUM POLYACRYLATE (2500000 MW) ACAI CARROT COCONUT STARCH, TAPIOCA THIOCTIC ACID UBIDECARENONE SALICYLIC ACID SALICYLIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.
Drug Facts
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.
Drug Facts
Other information Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contaact Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contaact Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
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.
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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
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.
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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API