FUNGI NAIL TOE AND FOOT PEN- undecylenic acid liquid
Kramer Laboratories

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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Undecylenic acid 25%

Antifungal

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.

Uses ■ proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
■ for effective relief of itching, bur ning and cracking.

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 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.

Isopropyl Palmitate

For external use only

carton image

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N)	Undecylenic acid	250 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55505-167-20	1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	12/05/2010	08/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	12/05/2010	08/31/2018

Labeler - Kramer Laboratories (122720675)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC		001207208	manufacture(55505-167)

Revised: 12/2017

Document Id: 38d924b2-218e-4743-9540-71fe8fc06956

Set id: ee23692f-7461-4cc7-8924-2f59cf71a4b9

Version: 7

Effective Time: 20171227

Kramer Laboratories