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| Product NDC Code | 68479-706 | ||||||||
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| Drug Name | Overnight clearing |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 346298 | ||||||||
| Application Number | part358H | ||||||||
| Labeler Name | Dermalogica, Inc. | ||||||||
| Packages |
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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 Ingredients Salicylic Acid 2.0%
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. Cover the affected area with a thin layer at night. Because too much drying of the skin may occur, start with 1 application daily at night, and if bothersome dryness or peeling occurs, reduce application to 2 to 3 times per week.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), PEG-32, Butylene Glycol, Salicylic Acid, PVM/MA Decadiene Crosspolymer, Polysorbate 20, Glycerin, PEG-60 Almond Glycerides, Mahonia Aquifolium Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Camellia Oleifera Leaf Extract, Spiraea Ulmaria Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Crithmum Maritimum Extract, Yeast Extract, Hydrogenated Vegetable Oil, Sodium Hyaluronate, Biotin, Panthenol, Caffeine, Niacinamide, Dipotassium Glycyrrhizate, Camphor, 10-Hydroxydecanoic Acid, Sebacic Acid, 1,10-Decanediol, Nordihydroquaiaretic Acid, Oleanolic Acid, Xanthan Gum, Carbomer, PEG-40 Hydrogenated Castor Oil, Ammonium Glycyrrhizate, Zinc Gluconate, Zinc Acetate, Sodium Hydroxide, Caprylic/Capric Triglyceride, Chlorphenesin, Caprylyl Glycol, Phenoxyethanol, Limonene, Linalool, Geraniol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Cymbopogon Martini Oil, Mentha Piperita (Peppermint) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Mentha Viridis (Spearmint) Leaf Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Artemisia Vulgaris Oil, Litsea Cubeba Fruit Oil, Piper Nigrum (Pepper) Seed Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Ocimum Basilicum (Basil) Oil, Cymbopogon Nardus (Citronella) Oil, Cinnamomum Zeylanicum Bark Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Salvia Officinalis (Sage) Oil, Thymus Vulgaris (Thyme) Oil.
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.For the treatment of acne.
Spl product data elements
Usually a list of ingredients in a drug product.Overnight Clearing Salicylic Acid Salicylic Acid Salicylic Acid Water Polyethylene Glycol 1500 Butylene Glycol Polysorbate 20 Glycerin PEG-60 Almond Glycerides BERBERIS AQUIFOLIUM ROOT Rosemary Camellia Oleifera Leaf Filipendula Ulmaria Root Horse Chestnut Crithmum Maritimum Yeast, Unspecified Hyaluronate Sodium Biotin Panthenol Caffeine Niacinamide Glycyrrhizinate Dipotassium Camphor (Synthetic) 10-Hydroxydecanoic Acid Sebacic Acid 1,10-Decanediol Masoprocol Oleanolic Acid Xanthan Gum Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) Polyoxyl 40 Hydrogenated Castor Oil Ammonium Glycyrrhizate Zinc Gluconate Zinc Acetate Sodium Hydroxide Medium-Chain Triglycerides Chlorphenesin Caprylyl Glycol Phenoxyethanol Tea Tree Oil Rosemary Oil Palmarosa Oil Peppermint Oil Citrus Maxima Fruit Rind Oil Lemon Oil Fennel Oil Spearmint Oil Pelargonium Graveolens Flower Oil Eucalyptus Oil Ginger Oil Artemisia Vulgaris Top Oil Litsea Oil White Pepper Oil Nutmeg Oil Basil Oil Citronella Oil Cinnamon Bark Oil Orange Oil Lavender Oil Sage Oil Thyme Oil
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 - 50 mL Bottle Carton overnight clearing gel acne treatment mediBac clearing ® 1.7 US FL OZ 50 mL e dermalogica ® Principal Display Panel - 50 mL Bottle 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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on broken skin or on large areas of the body.
Do not use in or near eyes.
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 US.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a Doctor if rash occurs.
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 Apply to affected areas only Skin irritation and dryness is 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. Avoid unnecessary sun exposure and use a sunscreen.
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. Do not use on broken skin or on large areas of the body. When using this product Apply to affected areas only Skin irritation and dryness is 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. Avoid unnecessary sun exposure and use a sunscreen. Do not use in or near eyes. Stop use and ask a Doctor if rash occurs. 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