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, or Poison Control Center right away.

Uses
 proven clinically effective in the treatment of most athlete’s foot (tinea
pedis), ringworm (tinea corporis) and jock itch (tinea cruris).
 for effective relief of itching, burning and cracking.

Directions  Clean affected area and dry thoroughly.  Spray Hongo
Cura anti-fungal liquid onto 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 athlete’s foot and ringworm, 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 the scalp or nails.

Isopropyl Palmitate

Warnings
For external use only. Avoid contact with eyes
Do not use
 on children under 2 years of age unless directed by a doctor.
 for diaper rash.

image description

HONGO CURA  MS
undecylenic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-154
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-154-2960 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/14/201009/12/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/14/201009/12/2013
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmecuticals001207208manufacture(55505-154)

Revised: 1/2018
 
Kramer Laboratories