HC MAX HONGO CURA MS- undecylenic acid spray 
Denison Pharmaceuticals, LLC.

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.

----------

HC Max Hongo Cura Anti-Fungal Spray

Active ingredientPurpose
Undecylenic Acid 25%Anti-fungul

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.

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.

Stop use and ask a doctor if

  • For athlete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks
  • For jock itch, irritation occurs or if there is no improvement within 2 weeks.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental ingestion, contact a physician, or Poison Control Center right away

Directions

  • Clean affected area and dry thoroughly.
  • Spray HC Max™ 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

Other information  Protect from freezing. If freezing occurs warm to room temperature 15º-30ºC (59º-86ºF). 

Inactive ingredient

Isopropyl Palmitate

HC MAX HONGO CURA MS (UNDECYLENIC ACID) SPRAY

Label Image

HC MAX HONGO CURA  MS
undecylenic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1032-1260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2017
2NDC:0295-1032-0530 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201702/06/2019
3NDC:0295-1032-111.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/201702/06/2019
4NDC:0295-1032-163 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/201702/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2017
Labeler - Denison Pharmaceuticals, LLC. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC.001207208manufacture(0295-1032)

Revised: 2/2019
 
Denison Pharmaceuticals, LLC.