Label: FUNGI NAIL TOE AND FOOT PEN- undecylenic acid liquid
- NDC Code(s): 55505-187-51
- Packager: Kramer Laboratories
- 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 January 8, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- WHEN USING
- INDICATIONS & USAGE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
Directions ■ Clean affected area 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 on skin around the nail and cuticle area. ■ Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. ■ For athlete's foot pay special attention to space between the toes. ■ For athlete's foot and ringworm, use daily for 4 weeks. ■ For toe fungus, apply under nail and cuticle area. If condition persists longer, consult a doctor. ■ 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
#1 Pharmacist Recommended
Clinically Proven to Cure Fungal Infections
TRIPLE ACTION FORMULA
✓ Kills Fungus
✓ Stops Itching & Burning
✓ Restores Skin Health
.101 FL OZ (3ml)
Instructions for Use:
Twist base with brush pointing downward to saturate brush (Figure1). If you do not hear a click, turn the other way. First time use may require several twists to initiate product flow. Please note product is clear: apply brush to skin to confirm proper dispersion of solution.
FUNGI-NAIL ANTI-FUNGAL PEN is the No-Mess, No-Spill, targeted treatment pen applicator that delivers the right amount of treatment right where you need it.
Fungi-Nail Is Specially Formulated:
Clear water-resistant barrier locks medicine in.
Kills fungus and restores skin.
For best results treat around all toenails and in between toes.
Not for nail or scalp fungus.
Cures most athlete's foot.
CLINICALLY PROVEN MEDICINE
Convenient and easy to Apply Pen Applicator
Deep Penetrating Medicine that Stays in Place
Restores Skin Health
DO NOT USE IF NECKBAND IS BROKEN OR MISSING
For more information about Fungi-Nail and money back guarantee, visit us at funginail.com
Kramer Laboratories, Inc.
Coral Gables, FL 33134
25% UNDECYLENIC ACID
TOE & FOOT® BRAND
ANTI-FUNGAL SOLUTION PEN
0.101 FL OZ (3mL)
Directions: Clean affected area with soap and water. Dry thoroughly. Twist pen base to saturate brush, then only as needed. Do not over twist. Apply around cuticle and underneath the edge of the nail twice daily.
Keep carton for complete information.
TWIST TOP TO BREAK SEAL OR PEEL HERE
SEALED FOR YOUR PROTECTION
FOR EXTERNAL USE ONLY.
DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN, TORN OR MISSING.
INGREDIENTS AND APPEARANCE
FUNGI NAIL TOE AND FOOT PEN
undecylenic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-187 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:55505-187-51 1 in 1 CARTON 04/17/2015 1 3 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 04/17/2015 Labeler - Kramer Laboratories (122720675) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 manufacture(55505-187)