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| Product NDC Code | 63736-339 | ||||
|---|---|---|---|---|---|
| Drug Name | Dermarest eczema medicated |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 103403 | ||||
| Application Number | part348 | ||||
| Labeler Name | Insight Pharmaceuticals 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 Hydrocortisone 1%
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 adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily children under 2 years of age do not use, consult a doctor
| adults and children 2 years of age and older | apply to affected area not more than 3 to 4 times daily |
| children under 2 years of age | do not use, consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Purified water, propylene glycol, glycerin, cetyl alcohol, glyceryl stearate, dimethicone, aleurites moluccana seed oil, zinc PCA, panthenol, carthamus tinctorius (safflower) flower extract, camellia sinensis leaf extract, rheum palmatum root/stalk extract, cyclohexasiloxane, cyclopentasiloxane, xanthan gum, disodium edetate, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben
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 temporary relief of itching associated with minor skin irritations inflammation rashes due to eczema Other uses of this product should be only under the advice and supervision of a doctor.
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Dermarest Eczema Medicated Hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER PROPYLENE GLYCOL GLYCERIN CETYL ALCOHOL GLYCERYL MONOSTEARATE DIMETHICONE KUKUI NUT OIL ZINC PIDOLATE PANTHENOL SAFFLOWER GREEN TEA LEAF RHEUM PALMATUM ROOT CYCLOMETHICONE 6 CYCLOMETHICONE 5 XANTHAN GUM EDETATE DISODIUM SODIUM HYDROXIDE DIAZOLIDINYL UREA METHYLPARABEN PROPYLPARABEN
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 Dermarest ® Eczema Medicated Lotion Hydrocortisone 1% Anti-Itch Lotion 4 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL Dermarest® Eczema Medicated Lotion Hydrocortisone 1% Anti-Itch Lotion 4 FL OZ (118 mL)
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.Dermarest ™ Eczema Medicated Lotion Keep carton for future reference. Drug Facts
Other Information shake well store at room temperature 15° - 25°C (59°- 77°F)
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 for the treatment of diaper rash
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 (1-800-222-1222) 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? 1-800-344-7239 www.Dermarest.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 persist for more than 7 days symptoms clear up and occur again within a few days Do not begin use of any other hydrocortisone product unless you have consulted a doctor.
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 the 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 Do not use for the treatment of diaper rash When using this product do not get into the eyes. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days Do not begin use of any other hydrocortisone product unless you have consulted a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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