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Product NDC Code | 59899-002 | ||||
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Drug Name | Enfuselle acne clarifying |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 199134 | ||||
Application Number | M006 | ||||
Labeler Name | Shaklee Corporation | ||||
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 for Use Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 Water/Eau, SD Alcohol 40-B, Cyclodextrin, Polysorbate 20, Xanthan Gum, 4-Terpineol*, Triethanolamine, Galactoarabinan, Zinc Gluconate, Sodium Coco PG-Dimonium Chloride Phosphate, Leptospermum Scoparium Branch/Leaf Oil, Tocopheryl Acetate, Dipostassium Glycyrrhizate, Panthenol, Disodium EDTA, Cetearyl Ethylhexanoate, Butylene Glycol, Nasturtium Officinale Extract, Arctium Lappa Root Extract, Aloe Barbadensis Leaf Juice, Pyridoxine HCL, Retinyl Palmitate.
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.Uses 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.enfuselle Acne Clarifying SALICYLIC ACID WATER XANTHAN GUM 4-TERPINEOL, (+/-)- TROLAMINE GALACTOARABINAN ZINC GLUCONATE MANUKA OIL .ALPHA.-TOCOPHEROL ACETATE GLYCYRRHIZINATE DIPOTASSIUM PANTHENOL EDETATE DISODIUM CETEARYL ETHYLHEXANOATE BUTYLENE GLYCOL NASTURTIUM OFFICINALE ARCTIUM LAPPA ROOT ALOE VERA LEAF PYRIDOXINE HYDROCHLORIDE VITAMIN A PALMITATE 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.Principal Labeling PARABEN FREE salicylic acid acne treatment 1fl. oz. 29mL 120applications All Skin Types This exclusive treatment formula gently and comprehensively controls the factors that contribute to the cycle of acne-troubled skin. Features an exclusive blend of nourishing antioxidants and purifying botanicals to help normalize sebum, unclog pores, speed healing, and reduce redness caused by acne. With continued use, skin will become visibly smoother, clearer, and shine free. Shaklee Dist. by/par Shaklee Corporation 4747 Willow Road Pleasanton, CA 94588 USA Item #39075 • Breakthrough patented formula • Contains botanical extracts: - tea tree (Melaleuca alternifolia) oil - manuka (Leptospermum scoparium) oil - licorice (Dipotassium glycyrrhizate) extract - burdock (Arctium lappa) root extract - watercress (Nasturtium officinale) extract - aloe vera (Aloe barbadensis) leaf juice • Features antioxidant vitamins A and E • Gentle enough to use daily for maximum acne control • 100% fragrance and paraben free • Allergy tested • Clinically formulated • Dermatologist tested Do not store at temperatures above 10O°F. U.S. Palent: 6,403,110 Apply this exclusive facial formula to help keep skin blemish free, speed healing and reduce redness caused by acne. Gentle enough to use daily, this unique blend of botanicals and nourishing antioxidants effectively controls the factors that contribute to the cycle of acnetroubled skin. WARNINGS: For external use only. Keep out of eyes. “Keep out of reach of children. If excessive dryness or peeling occurs, reduce the application to once a day or every other day. Directions: Apply one to three times daily after cleansing and toning. Allow to dry after application. Follow with the Enfuselle treatment or moisturizer for your skin type. Not tested on animals 100% free of occlusive oils
Package Labeling: 1
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. In swallowed, get medical help or contact a 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 if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time. Keep out of eyes. Rinse with water to remove.
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.
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