FUNGI NAIL TOE AND FOOT ANTI-FUNGAL- undecylenic acid solution 
Denison Pharmaceuticals, LLC.

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.

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FungiNail Toe and Foot Anti-Fungal Solution


Active ingredient....................Purpose

Undecylenic Acid.....................Anti-fungal

Uses ■ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis). ■ For effective relief of itching, burning and cracking.

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product ■ avoid contact with eyes.

Stop use and ask a doctor if ■ Irritation occurs. ■ There is no improvement within 4 weeks.

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 Center immediately for advice.

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.

Other information Store at room temperature 15°-30° C (59°-86° F). Protect from freezing. If freezing occurs warm to room temperature.

Inactive ingredient

Isopropyl Palmitate

label

FUNGI NAIL TOE AND FOOT ANTI-FUNGAL 
undecylenic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9032-051 in 1 CARTON02/06/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0295-9032-161 in 1 CARTON02/06/2019
23 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
3NDC:0295-9032-111 in 1 CARTON02/06/2019
31.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/06/2019
Labeler - Denison Pharmaceuticals, LLC. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC.001207208manufacture(0295-9032)

Revised: 2/2019
 
Denison Pharmaceuticals, LLC.