Fungi Nail Double Strength: Package Insert and Label Information

FUNGI NAIL DOUBLE STRENGTH- 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.

Undecylenic acid 25%

Antifungal

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) ■ helps prevent most athlete’s foot with
daily use ■ for effective relief of itching, burning
and cracking

Directions ■ Clean affected area with soap and
warm water and dry thoroughly. ■ Apply a thin
layer of Fungi-Nail® Brand 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. 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.

Isopropyl Palmitate

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.

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FUNGI NAIL DOUBLE STRENGTH undecylenic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Undecylenic acid (Undecylenic acid ) Undecylenic acid 250 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL PALMITATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55505-103-26 30 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 12/07/2010
Labeler — Kramer Laboratories (122720675)
Establishment
Name Address ID/FEI Operations
Dension Pharmecuticals 001207208 manufacture

Revised: 12/2010 Kramer Laboratories

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