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| Product NDC Code | 62032-614 | ||||
|---|---|---|---|---|---|
| Drug Name | Clenziderm therapeutic moisturizer |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part347 | ||||
| Labeler Name | Obagi Cosmeceuticals LLC | ||||
| 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 ingredient Glycerin 20%
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 ▪ Apply as needed. ▪ Children under 6 months: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, butylparaben, cetyl dimethicone, corn starch modified, cyclopentasiloxane, dimethicone, dimenthicone/vinyl dimethicone crosspolymer, ethylparaben, isobutylparaben, lauryl PEG/PPG-18/18 methicone, methylparaben, phenoxyethanol, propylparaben, triethanolamine, water
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 ▪ Temporarily protects and helps relieve chapped or cracked skin. ▪ Helps protect from the drying effects of wind and cold weather.
Purpose
Information about the drug product’s indications for use.Purpose Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.CLENZIDERM THERAPEUTIC MOISTURIZER GLYCERIN GLYCERIN GLYCERIN ALLANTOIN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) CYCLOMETHICONE 5 LAURYL PEG/PPG-18/18 METHICONE DIMETHICONE TROLAMINE WATER PHENOXYETHANOL ETHYLPARABEN ISOBUTYLPARABEN BUTYLPARABEN PROPYLPARABEN METHYLPARABEN
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 Label OBAGI ® MEDICAL CLENZI derm M.D.™ Therapeutic Moisturizer Glycerin 20% Skin Protectant 1.7 fl. oz. (50 mL) Principal Display Panel - 50 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
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 ▪ deep or puncture wounds ▪ animal bites ▪ serious burns.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ▪ Store away from heat and direct sunlight. ▪ Store at controlled room temperature: 15°C–25°C (59°F–77°F)
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 and ask a doctor if ▪ condition worsens ▪ symptoms last more than 7 days or clear up and occur again within a few days.
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 ▪ do not get into eyes.
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 ▪ do not get into eyes. Stop and ask a doctor if ▪ condition worsens ▪ symptoms last more than 7 days or clear up and occur again within a few days. Do not use on ▪ deep or puncture wounds ▪ animal bites ▪ serious burns. 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