Etaderm Advanced Antifungal Support

Etaderm Advanced Antifungal Support
SPL v1
SPL
SPL Set ID adb12a1c-ece9-4a59-a62c-89d212c57e6f
Route
TOPICAL
Published
Effective Date 2024-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (250 mg)
Inactive Ingredients
Aloe Clove Oil Sunflower Oil Tea Tree Oil Menthol Olive Oil Almond Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-25

Description

Undecylenic Acid 25.00%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25.00%

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.
Warnings:

For external use only

Do Not Use
  • on children under 2 years of age unless directed by a doctor
Drug Facts

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.
Active Ingredient

Undecylenic Acid 25.00%

Package Labeling:

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

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).
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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

Antifungal

Warnings:

For external use only

Do Not Use (Do not use)
  • on children under 2 years of age unless directed by a doctor
Drug Facts

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.
Active Ingredient (Active ingredient)

Undecylenic Acid 25.00%

Package Labeling:

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

When Using This Product (When using this product)
  • Avoid contact with eyes.
Stop Use and Ask A Doctor If (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).
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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