9f12bfcb-c0f5-4113-996c-917976c01349

SPL v5
SPL
SPL Set ID 9f12bfcb-c0f5-4113-996c-917976c01349
Route
topical
Published
Effective Date 2018-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
undecylenic acid (0.23125 g)
Inactive Ingredients
propylene glycol dicaprylate limonene, (+)- linalool, (+)-

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-01-01

Purpose

Antifungal

Description

Undecylenic Acid 25%


Medication Information

Warnings

For external use only

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

Avoid contact with eyes.

Stop use and ask a doctor if:

  • irritation occurs
  • there is not improvement within 4 weeks.

Uses

cures most ringworm (tinea corporis) and athlete's foot (tinea pedis).

Soothes:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort
  • itchy, scaling skin between the toes
  • itching, burning feet
Purpose

Antifungal

Directions

Use daily for 4 weeks. This product is not effective on the scalp or nails.

  • wash 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, veniltated shoes
  • change shoes and socks at least once daily
Other Information
  • do not use if the printed seal is broken or missing prior to opening
  • keep away from direct sunlight
Inactive Ingredients

proplylene glycol dicaprylate/dicaprate, parfum/fragrance, limonene, linalool

Description

Undecylenic Acid 25%

Section 51945-4

Active Ingredient

Undecylenic Acid 25%

Questions Or Comments?

To report a serious adverse event and for informaiton or comments on this product call us at 1-800-953-5080

9:00AM-5:00PM EST or visit www.sallyhansen.com

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

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

Avoid contact with eyes.

Stop use and ask a doctor if:

  • irritation occurs
  • there is not improvement within 4 weeks.

Uses

cures most ringworm (tinea corporis) and athlete's foot (tinea pedis).

Soothes:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort
  • itchy, scaling skin between the toes
  • itching, burning feet
Purpose

Antifungal

Directions

Use daily for 4 weeks. This product is not effective on the scalp or nails.

  • wash 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, veniltated shoes
  • change shoes and socks at least once daily
Other Information
  • do not use if the printed seal is broken or missing prior to opening
  • keep away from direct sunlight
Inactive Ingredients (Inactive ingredients)

proplylene glycol dicaprylate/dicaprate, parfum/fragrance, limonene, linalool

Section 51945-4 (51945-4)

Active Ingredient

Undecylenic Acid 25%

Questions Or Comments? (Questions or comments?)

To report a serious adverse event and for informaiton or comments on this product call us at 1-800-953-5080

9:00AM-5:00PM EST or visit www.sallyhansen.com

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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