Hongo Cura MS: Package Insert and Label Information

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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:55505-154
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:55505-154-29 60 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 12/14/2010
Labeler — Kramer Laboratories (122720675)
Establishment
Name Address ID/FEI Operations
Denison Pharmecuticals 001207208 manufacture

Revised: 12/2010 Kramer Laboratories

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