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


image description

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
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
Bioplan Innovative Sampling Inc 079158231 manufacture(55505-167)

Revised: 11/2013
Document Id: c3180fd9-8758-47c3-aa2d-3b455200359c
Set id: ee23692f-7461-4cc7-8924-2f59cf71a4b9
Version: 4
Effective Time: 20131112
 
Kramer Laboratories