Label: FUNGI NAIL TOE AND FOOT ANTI-FUNGAL- undecylenic acid solution
- NDC Code(s): 0295-9032-05, 0295-9032-11, 0295-9032-16
- Packager: Denison Pharmaceuticals, 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 February 6, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
Directions ■ Clean affected areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail ® Toe & Foot ® Anti-fungal Solution over affected 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. ■ Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. ■ For athlete’s foot pay special attention to spaces between the toes. ■ For athlete’s foot and ringworm, use daily for 4 weeks. ■ This product is not effective on the scalp or nails. ■ Supervise children in the use of this product.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
FUNGI NAIL TOE AND FOOT ANTI-FUNGAL
undecylenic acid solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-9032 Route of Administration TOPICAL 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:0295-9032-05 1 in 1 CARTON 02/06/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0295-9032-16 1 in 1 CARTON 02/06/2019 2 3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 3 NDC:0295-9032-11 1 in 1 CARTON 02/06/2019 3 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 02/06/2019 Labeler - Denison Pharmaceuticals, LLC. (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC. 001207208 manufacture(0295-9032)