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La roche posay laboratoire dermatologique cicaplast defense b5 skin protectant - Medication Information

Product NDC Code 49967-586
Drug Name

La roche posay laboratoire dermatologique cicaplast defense b5 skin protectant

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]
Active Ingredients
Glycerin 10 mg/ml
Route TOPICAL
Dosage Form GEL
Application Number M016
Labeler Name L'Oreal USA Products Inc
Packages
Package NDC Code Description
49967-586-01 1 tube in 1 carton (49967-586-01) / 40 ml in 1 tube
49967-586-02 1 tube in 1 carton (49967-586-02) / 3 ml in 1 tube
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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 Skin Protectant 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