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Product NDC Code | 0259-2102 | ||||||
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Drug Name | Mederma stretch marks therapy |
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Type | Brand | ||||||
Pharm Class | Skin Barrier Activity [PE] | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 244642, 1483141 |
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Application Number | part347 | ||||||
Labeler Name | Merz Pharmaceuticals, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Dimethicone 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 Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Allium Cepae (Onion) Bulb Extract, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Glycerin, Pentylene Glycol, Cyclomethicone, Arachidyl Alcohol, Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ethoxydiglycol, Cetearyl Glucoside, Tocopheryl Acetate, Fragrance, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Disodium EDTA, Centella Asiatica Leaf Extract, Hydrolyzed Collagen, Hydrolyzed Soy Protein, Sodium Hydroxide, Iron Oxides.
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
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.Mederma Stretch Marks Therapy dimethicone dimethicone dimethicone water Edetate Disodium HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) ARACHIDYL ALCOHOL Docosanol ARACHIDYL GLUCOSIDE CETOSTEARYL ALCOHOL Cetearyl Glucoside Alkyl (C12-15) Benzoate Dicaprylyl Carbonate HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) FERRIC OXIDE RED .Alpha.-Tocopherol Acetate CYCLOMETHICONE ONION Glycerin PENTYLENE GLYCOL CENTELLA ASIATICA LEAF DIETHYLENE GLYCOL MONOETHYL ETHER BOVINE TYPE I COLLAGEN SOY PROTEIN HYALURONATE SODIUM SODIUM HYDROXIDE
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 - 150 g Tube Box MEDERMA ® stretch marks therapy Improve appearance Reduce discoloration Smooth texture Enhance softness Hydrates to HELP PREVENT stretch marks DERMATOLOGIST RECOMMENDED Clinically shown to produce noticeable improvement in just 4 weeks PARABEN FREE intensive cream and skin protectant NET WT. 5.29 OZ. (150g) PRINCIPAL DISPLAY PANEL - 150 g Tube Box
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.
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? For more information call 1-888-925-8989 or visit www.mederma.com
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 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature
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 use 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 If pregnant or breastfeeding, ask a health professional before use 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