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Product NDC Code | 69625-587 | ||||||
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Drug Name | La roche posay laboratoire dermatologique cicaplast defense b5 |
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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 | GEL | ||||||
Application Number | M016 | ||||||
Labeler Name | Cosmetique Active Production | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Glycerin 21%
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, dimethicone, panthenol, pentylene glycol, c30-45 alkyl dimethicone, polybutene, sodium citrate, PEG/PPG-18/18 dimethicone, citric acid, dimethiconol, polysorbate 20, madecassoside, caprylyl glycol, sodium hyaluronate, zinc gluconate, copper gluconate, manganese gluconate, tocopherol
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.La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Glycerin GLYCERIN GLYCERIN WATER DIMETHICONE PANTHENOL PENTYLENE GLYCOL C30-45 ALKYL METHICONE POLYBUTENE (1400 MW) SODIUM CITRATE PEG/PPG-18/18 DIMETHICONE CITRIC ACID MONOHYDRATE DIMETHICONOL (2000 CST) POLYSORBATE 20 MADECASSOSIDE CAPRYLYL GLYCOL HYALURONATE SODIUM ZINC GLUCONATE COPPER GLUCONATE MANGANESE GLUCONATE TOCOPHEROL
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.image of a carton
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? 1-888-LRP-LABO 1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)
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
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 F or external use only
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