Label: FUNGI NAIL TOE AND FOOT PEN- undecylenic acid liquid
- NDC Code(s): 55505-167-20
- Packager: Kramer Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Undecylenic acid 25%Close
- KEEP OUT OF REACH OF CHILDREN
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control CenterClose
immediately for advice.
- INDICATIONS & USAGE
Uses ■ proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)Close
■ for effective relief of itching, bur ning and cracking.
- DOSAGE & ADMINISTRATION
Directions ■ Clean affected are a with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail®Brand Toe & Foot™ Anti-Fungal Solution over affected areaClose
twice daily (morning and night) or as directed by a doctor. ■ The brush applicator allows for easy application under nails and surrounding cuticle area.
- INACTIVE INGREDIENT
For external use only
- INGREDIENTS AND APPEARANCE
FUNGI NAIL TOE AND FOOT PEN
undecylenic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-167 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N) Undecylenic acid 250 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55505-167-20 1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/05/2010 Labeler - Kramer Laboratories (122720675) Establishment Name Address ID/FEI Business Operations Qualis Packaging Inc. 078387992 manufacture(55505-167)