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Clenziderm pore therapy acne treatment - Medication Information

Product NDC Code 62032-612
Drug Name

Clenziderm pore therapy acne treatment

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 251577,
1235208
Application Number part333D
Labeler Name Obagi Cosmeceuticals LLC
Packages
Package NDC Code Description
62032-612-04 148 ml in 1 bottle, plastic (62032-612-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic acid 2%

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 Cleanse the skin thoroughly before applying this product. Shake product well before use. 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 benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

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 dries up acne pimples helps prevent new acne pimples

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.
CLENZIDERM PORE THERAPY ACNE TREATMENT SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID ALCOHOL DIETHYLENE GLYCOL MONOETHYL ETHER BENZYL ALCOHOL 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL CHAMOMILE GLYCERIN MENTHOL, UNSPECIFIED FORM MENTHYL LACTATE, (-)- EXT. D&C VIOLET NO. 2 WATER

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 - 148 mL Bottle Label OBAGI ® MEDICAL CLENZIderm M.D.™ Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL) Principal Display Panel - 148 mL Bottle Label

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 Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

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? 1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time

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 irritation becomes severe.

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store away from heat and direct sunlight store at controlled room temperature: 15°–25°C (59°–77°F)

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. Stop use and ask a doctor if irritation becomes severe. 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