Label: UNDECYLENIC ACID- maximum strength antifungal pen liquid
- NDC Code(s): 11673-260-17
- Packager: Target Corporation
- 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 October 26, 2016
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- Active ingredient
Undecylenic acid 25%w/wClose
For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).
For relief of:
- discomfort which may accompany these conditions
For external use only
Keep out of children.
If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.
Read all warnings 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 affecter area twice daily (morning and night) or as directed by a 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 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 conditions persists longer, consult a doctor
- this product is not effective on the scalp or nails
- Other information
- store at room temperature 15°-30°C (59° - 86°F)
- protect from freezing. If freezing occurs warm to room temperature
- keep tightly closed when not in use
- Inactive ingredient
- Principal Display Panel
Compare to active ingredient in Fungi-Nail®*
25% undecylenic acid
eliminates fungus on fingers, toes and around nails
pre-filled applicator pen brush
0.057 FL OZ (1.7mL)
25% undecylenic acid
This up & up® antifungal pen eliminates and helps stop the spread of fungal infections on cuticles, around nail edges and under nail tips where reachable with applicator brush. Topical antifungal treatment will not penetrate hard nail surfaces.
*This product is not manufactured or distributed by Kramer Laboratories, Inc., owner of the registered trademark Fungi-Nail®.
- INGREDIENTS AND APPEARANCE
maximum strength antifungal pen liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-260 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:11673-260-17 1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 04/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/01/2014 Labeler - Target Corporation (006961700)