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.

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic acid (Undecylenic acid ) Undecylenic acid 250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE 
Packaging
#Item CodePackage Description
1NDC:55505-103-2630 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/07/2010
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Dension Pharmecuticals001207208manufacture

Revised: 12/2010
 
Kramer Laboratories