Antifungal Treatment Liquid 25% Undeclylenic Acid

Antifungal Treatment Liquid 25% Undeclylenic Acid
SPL v4
SPL
SPL Set ID 2ae0f300-154e-44c8-bcc3-b5c334e661ac
Route
TOPICAL
Published
Effective Date 2023-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (250 mg)
Inactive Ingredients
Aloe Vera Leaf Canola Oil Clove Oil Lavender Oil Jojoba Oil Manuka Oil Oregano Leaf Oil Peppermint Oil Propolis Wax Almond Oil Tea Tree Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01

Description

Undecylenic Acid 25%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25%

Uses
  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort
Warnings

For external use only.

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 athlete'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; for jock itch, use daily for 2 weeks.If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Drug Facts

Do Not Use 
  • on children under 2 years of age unless directed by a doctor.
Active Ingredient

Undecylenic Acid 25%

Package Labeling:

Inactive Ingredients

Aloe Vera Extract, Canola Oil, Clove Bud Oil, Lavender Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond Oil, Tea Tree Oil, Tocopheryl Acetate

When Using This Product
  • avoid contact with the eyes.
Stop Use and Ask A Doctor If
  • irritation occurs or if 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
  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort
Purpose

Antifungal

Warnings

For external use only.

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 athlete'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; for jock itch, use daily for 2 weeks.If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Drug Facts

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

Undecylenic Acid 25%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Aloe Vera Extract, Canola Oil, Clove Bud Oil, Lavender Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond Oil, Tea Tree Oil, Tocopheryl Acetate

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 or if 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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