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Etaderm advanced antifungal support - Medication Information

Product NDC Code 84180-471
Drug Name

Etaderm advanced antifungal support

Type Brand
Active Ingredients
Undecylenic acid 250 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 2677799
Application Number M005
Labeler Name NUEPHASE LLC
Packages
Package NDC Code Description
84180-471-00 29 ml in 1 jar (84180-471-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Undecylenic Acid 25.00% Purpose Antifungal

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: Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For arthlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. This product is no effective on the scalp or nails.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Aloe Extract, Eugenia Caryophyllus (Clove) Bud Oil, Helianthus Annuus (Sunflower) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Menthol, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).

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: For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm). For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections.

Purpose

Information about the drug product’s indications for use.
Purpose Antifungal

Spl product data elements

Usually a list of ingredients in a drug product.
ETADERM Advanced Antifungal Support UNDECYLENIC ACID ALOE CLOVE OIL SUNFLOWER OIL TEA TREE OIL MENTHOL OLIVE OIL ALMOND OIL .ALPHA.-TOCOPHEROL ACETATE UNDECYLENIC ACID UNDECYLENIC ACID

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.
Package Labeling: Label

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 Other Information: Protect the product in this container from excessive heat and direct sun.

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 children under 2 years of age unless directed by a doctor

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.

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 If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch).

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 Avoid contact with eyes.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

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 on children under 2 years of age unless directed by a doctor When using this product Avoid contact with eyes. Stop use and ask a doctor if If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch). Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

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