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

Purpose

Antifungal

Description

Active Ingredient Undecylenic acid 25% w/v


Medication Information

Warnings

For external use only

Flammable:Keep away from fire or flame.

Uses

For the cure of:

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

For the relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
Purpose

Antifungal

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.

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

Description

Active Ingredient Undecylenic acid 25% w/v

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.

Drug Facts

Active Ingredient



Undecylenic acid 25% w/v

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

Warnings

For external use only

Flammable:Keep away from fire or flame.

Uses

For the cure of:

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

For the relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
Purpose

Antifungal

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.

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

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.

Drug Facts

Active Ingredient



Undecylenic acid 25% w/v

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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