Emoninail Antifungal Solution

Emoninail Antifungal Solution
SPL v2
SPL
SPL Set ID 84ace47a-d3ae-4735-87b6-dbbf1c40cf54
Route
TOPICAL
Published
Effective Date 2020-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (100 mg)
Inactive Ingredients
Water Cetostearyl Alcohol Sunflower Oil Cetyl Alcohol Polysorbate 20 C13-14 Isoparaffin Laureth-7 Glycerin Tea Tree Oil Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-01

Description

Undecylenic Acid 10.00%

Purpose

Topical Antifungal


Medication Information

Purpose

Topical Antifungal

Description

Undecylenic Acid 10.00%

Uses

Proven clinically effective in the treatment of most fungal infections related/associated to tinea pedis (athlete's foot) or tinea corporis (ringworm).

Warnings
  • For external use only
Directions
  • 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, ventilated shoes, and change shoes andsocks 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.
Do Not Use
  • on children under 2 years of age, unless directed by a doctor.
Active Ingredient

Undecylenic Acid 10.00%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Other Information

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

Inactive Ingredients

Aqua (Deionized Water), SD-Alcohol 40B, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Alcohol, Polysorbate-20, Polycrylamide, C13-C14 Isoparaffin, Laureth-7, Glycerin, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Ethylhexyglycerin.

When Using This Product,

avoid contact with eyes.

Stop Use and Ask A Doctor If,
  • If irritation occurs or if 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

Proven clinically effective in the treatment of most fungal infections related/associated to tinea pedis (athlete's foot) or tinea corporis (ringworm).

Purpose

Topical Antifungal

Warnings
  • For external use only
Directions
  • 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, ventilated shoes, and change shoes andsocks 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.
Do Not Use (Do not use)
  • on children under 2 years of age, unless directed by a doctor.
Active Ingredient

Undecylenic Acid 10.00%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Other Information (Other information)

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

Inactive Ingredients

Aqua (Deionized Water), SD-Alcohol 40B, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Alcohol, Polysorbate-20, Polycrylamide, C13-C14 Isoparaffin, Laureth-7, Glycerin, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Ethylhexyglycerin.

When Using This Product, (When using this product,)

avoid contact with eyes.

Stop Use and Ask A Doctor If, (Stop use and ask a doctor if,)
  • If irritation occurs or if 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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