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| Product NDC Code | 73302-204 | ||||
|---|---|---|---|---|---|
| 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 | M016 | ||||
| Labeler Name | HRA PHARMA AMERICA, INC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Pentylene Glycol, Dicaprylyl Carbonate, Glycerin, Arachidyl Alcohol, Alcohol, Cyclopentasiloxane, Behenyl Alcohol, Cyclohexasiloxane, Ethoxydiglycol, Arachidyl Glucoside, Allium Cepa (Onion) Bulb Extract, Cetearyl Glucoside, Tocopheryl Acetate, Sodium Hyaluronate, Fragrance, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Disodium EDTA, Hydrolyzed Collagen, Asiaticoside, Asiatic Acid, Madecassic Acid, Polysorbate 60, Sorbitan Isostearate, Hydrolyzed Soy Protein, Sodium Hydroxide, Tocopherol, Iron Oxides, Sodium Benzoate
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 Cetostearyl Alcohol Alkyl (C12-15) Benzoate Pentylene Glycol Dicaprylyl Carbonate Glycerin Arachidyl Alcohol Alcohol Cyclomethicone 5 Docosanol Cyclomethicone 6 Diethylene Glycol Monoethyl Ether Arachidyl Glucoside Onion Cetearyl Glucoside .Alpha.-Tocopherol Acetate Hyaluronate Sodium Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.S At 1.5%) Hydroxyethyl Cellulose (2000 Mpa.S At 1%) Edetate Disodium Anhydrous Bovine Type I Collagen Asiaticoside Asiatic Acid Madecassic Acid Polysorbate 60 Sorbitan Isostearate Soy Protein Sodium Hydroxide Tocopherol Ferric Oxide Red Sodium Benzoate
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 MEDERMA ® Stretch Marks Therapy Clinically shown to treat stretch marks by: ● Hydrating the skin ● Reducing discoloration ● Improving texture No 1 Doctor & Pharmacist recommended scar brand Skin Protectant 1x CREAM TUBE NET WT. 5.29 Oz (150g) Unique Triple-Action Formula penetrates into the skin Carton Label
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 punctured 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 at room temperature
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 1-833-426-6733 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
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 punctured 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