Otc - Active Ingredient
Section from Carton Label Follows:Active ingredient PurposeUndecylenic acid 25% w/v.......Antifungal
Undecylenic Acid
FDA Label NDC 59779-132
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Undecylenic Acid (NDC 59779-132). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Section from Carton Label Follows:Active ingredient PurposeUndecylenic Acid 25% w/v.................AntifungalUsesTreats most athletes foot (tinea pedis) and ringworm (tinea corporis)
Otc - Keep Out Of Reach Of Children
Section from Warnings section of Carton label follows:KEEP THIS AND ALL MEDICATION OUTOF THE REACH OF CHILDRENIf accidental ingestion occurs, immediately contact a physician,emergency medical facility or PoisonControl Center for help.
Indications & Usage
Section from Directions portion of carton label follows:
Directions
- Using soap and water, clean 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.
- Use the brush applicator provided for
easy application to the affected area
- For toe usage, change shoes and socks
at least once daily and wear well fitting,
ventilated shoes
- Pay particular attention to spaces
between the toes for athletes foot
- For athletes foot and ringworm, use the
product daily for 4 weeks. If condition
persists longer, consult a physician
- This product is not effective on the scalp
or nails
- Children must be supervised in the use
of this product
Warnings
From Warnings Section of Carton Label:Warnings For external use only. ______________________________Ask a doctor before use on children under 2 years of age____________________________________When using this productavoid contact with the eyes____________________________________Stop use and consult a doctor if- Irritation occurs - you do not noticeimprovement within 4 weeks____________________________________KEEP THIS AND ALL MEDICATION OUTOF THE REACH OF CHILDRENIf accidental ingestion occurs, immediately contact a physician,emergency medical facility or PoisonControl Center for help.
Dosage & Administration
Section from Directions portion of carton label follows:Directions- Using soap and water, clean 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. - Use the brush applicator provided for easy application to the affected area- For toe usage, change shoes and socks at least once daily and wear well fitting, ventilated shoes- Pay particular attention to spaces between the toes for athletes foot- For athletes foot and ringworm, use the product daily for 4 weeks. If condition persists longer, consult a physician- This product is not effective on the scalp or nails- Children must be supervised in the use of this product
Inactive Ingredient
From Inactive Ingredients section of Carton Label:Inactive Ingredients Isopropyl Palmitate
Package Label.Principal Display Panel
Carton
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