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| Product NDC Code | 68479-013 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sebum clearing masque |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| RxCUI drug identifier | 865105 | ||||||||||
| Application Number | part358H | ||||||||||
| Labeler Name | Dermalogica | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid (0.5%)
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.Directions Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times per week. Leave on for 10 minutes then rinse thoroughly with warm water. If bothersome dryness or peeling occurs, reduce application to once a week or every other week.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua/Eau, Kaolin, Bentonite, Glycerin, Polysorbate 20, Pentylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Butylene Glycol, Glyceryl Stearate SE, Polysorbate 60, Avena Sativa (Oat) Kernel Extract, Bisabolol, Spiraea Ulmaria Extract, Menthol, 10-Hydroxydecanoic Acid, Sebacic Acid, 1,10-Decanediol, Camphor, Farnesyl Acetate, Panthenyl Triacetate, Tocopheryl Acetate, Dipotassium Glycyrrhizate, Cinnamomum Zeylanicum Bark Extract, Sarcosine, Niacinamide, Yeast Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Ammonium Glycyrrhizate, Panthenol, Zinc Gluconate, Caffeine, Biotin, Hydroxyethylcellulose, Disodium EDTA, Capryloyl Glycine, 1,2-Hexanediol, Tropolone, Caprylyl Glycol, Caprylhydroxamic Acid, Ethylhexylglycerin, Methylpropanediol, Titanium Dioxide (CI 77891), Zinc Oxide (CI 77947).
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.Indications For the treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.Sebum Clearing Masque Salicylic Acid Salicylic Acid Salicylic Acid Water Kaolin Bentonite Glycerin Polysorbate 20 Pentylene Glycol Safflower Oil Cetostearyl Alcohol Butylene Glycol Glyceryl Stearate SE Polysorbate 60 Oat Levomenol Filipendula Ulmaria Root Menthol, Unspecified Form 10-Hydroxydecanoic Acid Sebacic Acid 1,10-Decanediol Camphor (Synthetic) Farnesyl Acetate Panthenol Triacetate, (+)- .Alpha.-Tocopherol Acetate Glycyrrhizinate Dipotassium Cinnamon Bark Oil Sarcosine Niacinamide Yeast, Unspecified Horse Chestnut Ammonium Glycyrrhizate Panthenol Zinc Gluconate Caffeine Biotin Hydroxyethyl Cellulose (6500 MPA.S at 2%) Edetate Disodium Capryloyl Glycine 1,2-Hexanediol Tropolone Caprylyl Glycol Caprylhydroxamic Acid Ethylhexylglycerin Methylpropanediol Titanium Dioxide Zinc Oxide
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.PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton sebum clearing masque purify oily skin Active Clearing 2.5 US FL OZ / 75 mL ℮ dermalogica Principal Display Panel - 75 mL Tube Carton
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
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 a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call toll free 1-800-831-5150 in the USA
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 if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
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 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 medical help or contact a 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