Label: UNDECYLENIC ACID- antifungal pen liquid
- NDC Code(s): 49035-970-17
- Packager: Wal-Mart Stores, 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.
Updated July 12, 2021
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- Active ingredient
For external use only
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
- Principal Display Panel
INGREDIENTS AND APPEARANCE
antifungal pen liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-970 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:49035-970-17 1.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product 05/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/01/2017 Labeler - Wal-Mart Stores, Inc. (051957769)