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Product NDC Code | 51326-802 | ||||
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Drug Name | Dr. zenovia spot treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1488689 | ||||
Application Number | M006 | ||||
Labeler Name | Topiderm, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzoyl Peroxide 5.0%
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 Blend a thin layer to affected area. Use once a day and increase to two or three times daily as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Bakuchiol, Camellia Sinensis (Green Tea) Polyphenols, Carbomer, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Punica Granatum Sterols, Purified Water, Resveratrol, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Genistein, Stearic Acid USP, Tocopheryl Acetate.
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 and management of acne Penetrates pores to eliminate most acne and blemishes Helps prevent development of new acne blemishes and blackheads
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.Dr. Zenovia Spot Treatment Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE ALOE VERA LEAF BAKUCHIOL GREEN TEA LEAF CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CUCUMBER GLYCERIN PUNICA GRANATUM STEROLS WATER RESVERATROL SODIUM HYDROXYMETHYLGLYCINATE SODIUM LAUROYL SARCOSINATE GENISTEIN STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE, DL-
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 - 15 mL Bottle Carton DR. ZENOVIA HORMONAL DERMATOLOGY CLEAR COMPLEXION 5% BENZOYL PEROXIDE ACNE SPOT TREATMENT bakuchiol, antioxidants reduces acne flare-ups and redness 15 mL / 0.5 Fl. Oz. PRINCIPAL DISPLAY PANEL - 15 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
REG-ulate360 Active Complex™ Resveratrol, Bakuchiol, Genistein, Camellia Sinensis (Green Tea) Polyphenols, Aloe Barbadensis Leaf Juice, Cucumis Sativus (Cucumber) Fruit Extract.
Distributed by Dr. Zenovia Skincare Babylon, NY 11704
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 product is 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? Call (800) 445-2595 or visit drzenovia.com
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 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 contact with eyes. If contact occurs, flush 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 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 contact with eyes. If contact occurs, flush thoroughly with water. Keep out of reach of children. If product is 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