Human Science Antifungal Foot Care

Human Science Antifungal Foot Care
SPL v3
SPL
SPL Set ID 26b2519b-7d7b-4b33-b5d6-a41fe6f73538
Route
TOPICAL
Published
Effective Date 2020-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (250 mg)
Inactive Ingredients
Dimethyl Sulfoxide Diethylene Glycol Monoethyl Ether Clove Oil Sunflower Oil Isopropyl Myristate Melaleuca Alternifolia Leaf Methyl Salicylate Thyme

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-14

Description

Undecylenic Acid 25.00%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25.00%

Uses:
  • For effective relief of itching, burning and cracking.
Warnings:
  • For external use only.
Do Not Use

on children under 2 years of age except under the supervision of a doctor.

Drug Facts

Directions:
  • Wash affected area well, and dry thoroughly.
  • Supervise, children in the use of this product.
  • For arthlete's foot:pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change socks at least once daily.
  • Use 1-2 times daily or as directed by physician.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.
Active Ingredient

Undecylenic Acid 25.00%

Package Labeling:

Other Information:

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

Inactive Ingredients:

Dimethyl Sulfoxid (DMSO), Ethoxydigilcol, Eugenia Caryophyllus (Clove) Bud oil, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Melaleuca Alternifolia (Tea Tree) Oil, Methyl Salicylate, Thymus Vulgaris (Thyme) Extract.

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses:
  • For effective relief of itching, burning and cracking.
Purpose

Antifungal

Warnings:
  • For external use only.
Do Not Use (Do not use)

on children under 2 years of age except under the supervision of a doctor.

Drug Facts

Directions:
  • Wash affected area well, and dry thoroughly.
  • Supervise, children in the use of this product.
  • For arthlete's foot:pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change socks at least once daily.
  • Use 1-2 times daily or as directed by physician.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.
Active Ingredient

Undecylenic Acid 25.00%

Package Labeling:

Other Information:

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

Inactive Ingredients:

Dimethyl Sulfoxid (DMSO), Ethoxydigilcol, Eugenia Caryophyllus (Clove) Bud oil, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Melaleuca Alternifolia (Tea Tree) Oil, Methyl Salicylate, Thymus Vulgaris (Thyme) Extract.

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.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

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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