Elon Dual Defense Anti-fungal Formula

Elon Dual Defense Anti-fungal Formula
SPL v3
SPL
SPL Set ID 45c4567d-7876-6459-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (250 mg)
Inactive Ingredients
Water Calendula Officinalis Flower Citrus Maxima Seed Alcohol Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-02

Description

Undecylenic Acid 25.0%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25.0%

Uses

Proven clinically effective in the treatment of most athletes's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use.

For effective relief of:

Itching Burning Cracking

Warnings

For external use only.

Directions
  • Wash affected area well, and let product sit for 1-2 minutes before rinsing.
  • Make sure to dry affected area thoroughly.
  • Supervise children in the use of this product
  • For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at leat once daily
  • Use 1-2 times daily.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor
  • This product is not effective on the scalp or nails
Do Not Use 

on children under 2 years of age except under the supervision of a doctor.

Other Information

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

Active Ingredients:

Undecylenic Acid 25.0%

Inactive Ingredients:

Aqua (Deionized Water), Calendula Officianalis Extract, Citrus Grandis (Grapefruit) Seed Extract, Ethyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil.

When Using This Product 

avoid contact with the eyes.

Stop Use and Ask A Doctor If:

Irritation occurs There is no improvement within 4 weeks

Keep Out of Reach of Children.

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


Structured Label Content

Uses

Proven clinically effective in the treatment of most athletes's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use.

For effective relief of:

Itching Burning Cracking

Purpose

Antifungal

Warnings

For external use only.

Directions
  • Wash affected area well, and let product sit for 1-2 minutes before rinsing.
  • Make sure to dry affected area thoroughly.
  • Supervise children in the use of this product
  • For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at leat once daily
  • Use 1-2 times daily.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor
  • This product is not effective on the scalp or nails
Do Not Use  (Do not use )

on children under 2 years of age except under the supervision of a doctor.

Other Information (Other information)

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

Active Ingredients: (Active ingredients:)

Undecylenic Acid 25.0%

Inactive Ingredients: (Inactive ingredients:)

Aqua (Deionized Water), Calendula Officianalis Extract, Citrus Grandis (Grapefruit) Seed Extract, Ethyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil.

When Using This Product  (When using this product )

avoid contact with the eyes.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Irritation occurs There is no improvement within 4 weeks

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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