Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 454c3458-7e52-0e5e-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (0.25 g)
Inactive Ingredients
Aloe Vera Leaf Hypromelloses Isopropyl Alcohol .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-05-01

Description

Active Ingredient Undecylenic acid 25% w/v

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Active Ingredient Undecylenic acid 25% w/v

Uses

For the cure of:

  • ringworm (tinea corporis)
  • athlete's foot (tinea pedis)

For the relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor.

Section 51945-4

Section 53414-9

If pregnant or breastfeeding ask a health professional before use.

Warnings

For external use only

Flammable:Keep away from fire or flame.

Directions
  • Read all warnings and directions.
  • Use only as directed.
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of product over the 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.  If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Drug Facts

Active Ingredient



Undecylenic acid 25% w/v

Other Information
  • Store at 20 o-25 oC (68 o-77 oF)
  • Keep container tightly closed when not in use.

Inactive Ingredients

Aloe barbadensis leaf juice, Fragrance, Hypromellose, Isopropyl alcohol, Tocopheryl acetate (Vitamin E), Water

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

For the cure of:

  • ringworm (tinea corporis)
  • athlete's foot (tinea pedis)

For the relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding ask a health professional before use.

Purpose

Antifungal

Warnings

For external use only

Flammable:Keep away from fire or flame.

Directions
  • Read all warnings and directions.
  • Use only as directed.
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of product over the 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.  If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Drug Facts

Active Ingredient



Undecylenic acid 25% w/v

Other Information (Other information)
  • Store at 20 o-25 oC (68 o-77 oF)
  • Keep container tightly closed when not in use.

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf juice, Fragrance, Hypromellose, Isopropyl alcohol, Tocopheryl acetate (Vitamin E), Water

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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