SPL v3
SPL
SPL Set ID 343573e1-6d65-428d-acaa-5485ed4b7add
Route
TOPICAL
Published
Effective Date 2022-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (200 mg)
Inactive Ingredients
Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-02-21

Description

Undecylenic Acid 20%.................Antifungal

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 20%.................Antifungal

Uses
  • For the treatment of most athelete's foot, jock itch and ringworm
  • For relief if itching, scaling, cracking, burning, redness, soreness, irritations, discomfort, chafing associated with jock itch
  • For the relief of itch, scaly skin between toes
  • Clears up most athelete's foot infection and with daily use helps keep it from comming back
Section 51945-4

Warnings

For external use only. Avoid contact with the eyes.

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 use of this product. For athelete'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 athelete'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.

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

Undecylenic Acid 20%.................Antifungal

Other Information
  • Protect from freezing. If freezing occurs, warm to room temperature 70°-80° F.
  • TAMPER EVIDENT DISCLOSURE: Do not use if seal is torn, broken or missing.
Inactive Ingredients
  • isopropyl alcohol 99%, water
Stop Use and Ask Doctor If
  • For athelete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks.
  • For jock itch, if irritation occurs or if there is no improvement within 2 weeks.
If Pregnant Or Breast Feeding,

ask health professional before use. 

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • For the treatment of most athelete's foot, jock itch and ringworm
  • For relief if itching, scaling, cracking, burning, redness, soreness, irritations, discomfort, chafing associated with jock itch
  • For the relief of itch, scaly skin between toes
  • Clears up most athelete's foot infection and with daily use helps keep it from comming back
Section 51945-4 (51945-4)

Purpose

Antifungal

Warnings

For external use only. Avoid contact with the eyes.

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 use of this product. For athelete'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 athelete'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.

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

Undecylenic Acid 20%.................Antifungal

Other Information (Other information)
  • Protect from freezing. If freezing occurs, warm to room temperature 70°-80° F.
  • TAMPER EVIDENT DISCLOSURE: Do not use if seal is torn, broken or missing.
Inactive Ingredients (Inactive ingredients)
  • isopropyl alcohol 99%, water
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • For athelete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks.
  • For jock itch, if irritation occurs or if there is no improvement within 2 weeks.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask health professional before use. 

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

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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