Label: UNDECYLENIC ACID- antifungal pen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55319-055-17 - Packager: Family Dollar Services Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 15, 2017
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- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
Read all warning and directions. Use only as directed.
clean the affected area and dry thoroughly
twist pen base with 3 clicks to saturate brush
apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by the doctor
the brush applicator allows for easy application under nails and surrounding cuticle area
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 and socks 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 - Other information
- Inactive ingredient
- Questions?
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INGREDIENTS AND APPEARANCE
UNDECYLENIC ACID
antifungal pen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-055 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Undecylenic Acid (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) Undecylenic Acid 25 mg in 1.7 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-055-17 1.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product 12/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/15/2017 Labeler - Family Dollar Services Inc. (024472631)
