HONGO CURA RS- zinc undecylenate and undecylenic acid cream 
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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Zinc undecylenate  20%

Undecylenic acid    5%


antifungal

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

for the treatment of most athletes foot, jock itch and ring worm. for the relief of itchy, scaly skin between the toes. clears most athletes foot infection and with daily use, helps keep it from coming back.

Directions:
• clean the affected area and dry thoroughly
• apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
• For athlete's foot: pay special attention to spaces between the toes, wear well fitting, ventilated shoes, and change shoes and socks at least once daily
• For athletes foot and ring worm, use daily  for 4 weeks.
• for jock itch,  use daily for 2 weeks. If condition persists longer, consult a doctor.


Methylparaben, Propylparaben, white petrolatum

Warnings: For external use only.
Avoid contact with the eyes.
Do not use:
 on children under 2 years of age
 for diaper rash
 on scalp or nails

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HONGO CURA  RS
zinc undecylenate undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-146
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC UNDECYLENATE (ZINC UNDECYLENATE) ZINC UNDECYLENATE20 g  in 100 g
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
PROPYLPARABEN 
PETROLATUM 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-146-4828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/14/2010
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmecuticals001207208manufacture

Revised: 12/2010
 
Kramer Laboratories