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Sally Hansen

Coty US LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Undecylenic Acid 25%

Antifungal

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

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.

If swallowed, get medical help or contact a Poison Control Center right away.

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
  • do not use if the printed seal is broken or missing prior to opening
  • keep away from direct sunlight

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

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

Sally Hansen

Sally Hansen

Sally Hansen

Undecylenic Acid LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66184-151
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UNDECYLENIC ACID 0.23125 g

Inactive Ingredients

Ingredient Name Strength
propylene glycol dicaprylate
LIMONENE, (+)-
LINALOOL, (+)-

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66184-151-01 39.0 in 1 BOTTLE, DROPPER
2 NDC:66184-151-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2012-01-01


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