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 physician, emergency medical care facility or  Poison
Control Center immediatly for advise

eliminates fungal infections of the skin by inhibiting the growth and reproduction of fungal cells

clean affected area with soap and warm water and dry thoroughly. apply a thin layer over affected area twice daily or as directed by doctor

Isopropyl Palmitate

For external use only


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FUNGI NAIL  DOUBLE STRENGTH
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-167
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:55505-167-201.7 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/05/2010
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Celeste Health & Beauty829739833manufacture
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmecuticals001207208manufacture

Revised: 12/2010
Document Id: d35fedd6-af92-4bad-82a7-6a7846a01a33
Set id: ee23692f-7461-4cc7-8924-2f59cf71a4b9
Version: 1
Effective Time: 20101206
 
Kramer Laboratories