Label: UNDECYLENIC ACID- antifungal solution liquid
- NDC Code(s): 36800-372-30
- Packager: Topco Associates LLC
- 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 January 25, 2023
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- Active ingredient
For external use only.
Read all warnings and directions. Use only as directed.
- clean the affected area and dry thoroughly
- apply a thin layer of the product over the affected area twice daily (morning and evening) or as directed by a doctor
- 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 changes shoes and socks atleast 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 solution liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-372 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 7.5 g in 30 g Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-372-30 30 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/20/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/20/2013 Labeler - Topco Associates LLC (006935977)