FDA Label for Undecylenic Acid
View Indications, Usage & Precautions
Undecylenic Acid Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Section from Carton Label Follows:Active ingredient PurposeUndecylenic acid 25% w/v.......Antifungal
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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