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Dr. zenovia acne cleanser - Medication Information

Product NDC Code 51326-803
Drug Name

Dr. zenovia acne cleanser

Type Brand
Active Ingredients
Benzoyl peroxide 100 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 142034
Application Number M006
Labeler Name Topiderm, Inc.
Packages
Package NDC Code Description
51326-803-01 1 bottle, plastic in 1 box (51326-803-01) / 120 ml in 1 bottle, plastic
51326-803-02 1 tube in 1 box (51326-803-02) / 50 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Benzoyl Peroxide 10.0%

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 Pump a small amount of cleanser into dampened hands, and gently massage over face and neck using a circular motion. Rinse thoroughly with water and pat dry.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aloe Barbadensis Leaf Extract, Bakuchiol, Camellia Sinensis (Green Tea) Leaf Polyphenols, Carbomer, Cucumis Sativus (Cucumber) Fruit Extract, Disodium EDTA, Fragrance, Genistein, Glycerin, Maltodextrin, Phenoxyethanol, Punica Granatum Sterols, Purified Water, Resveratrol, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, 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 Acne Cleanser Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE ALOE VERA LEAF BAKUCHIOL GREEN TEA LEAF CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CUCUMBER JUICE EDETATE DISODIUM GLYCERIN MALTODEXTRIN PHENOXYETHANOL PUNICA GRANATUM STEROLS WATER RESVERATROL SODIUM BENZOATE SODIUM C14-16 OLEFIN SULFONATE 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 - 120 mL Bottle Carton DR. ZENOVIA HORMONAL DERMATOLOGY CLEAR COMPLEXION 10% BENZOYL PEROXIDE ACNE CLEANSER reg-ulate360 complex™, aloe vera, antioxidants removes excess sebum, impurities and buildup 120 mL / 4.0 Fl. Oz. PRINCIPAL DISPLAY PANEL - 120 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