HONGO CURA MS- undecylenic acid spray 
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  

antifungal

Keep out of reach of children. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advise

Uses
for the treatment of most athlete's foot,jock itch and ringworm.
for the relief of itching associated with jock itch.
for the relief of itch scaly skin between the toes.
clears up most athlete's 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. this product is not effective on scalp and nails

Isopropyl Palmitate

Warnings: For external use only.
Avoid contact with the eyes.

Do not use:

  • on children under 2 years of age unless directed by a doctor
  • for diaper rash

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HONGO CURA  MS
undecylenic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-154
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Isopropyl Palmitate 
Packaging
#Item CodePackage Description
1NDC:55505-154-2960 mL in 1 BOTTLE, SPRAY
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