HC MAX HONGO CURA- zinc undecylenate undecylenic acid ointment 
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.

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HC Max Hongo Cura

Active ingredientPurpose
Zinc Undecylenate 20% Anti-fungal
Undecylenic Acid 5% Anti-fungal

Uses ■ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis). ■ For effective relief of itching, burning and cracking.

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product ■ avoid contact with eyes.

Stop use and ask a doctor if ■ Irritation occurs. ■ There is no improvement within 4 weeks.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

Directions ■ Clean affected area with soap and warm water and dry thoroughly. ■ Apply a thin layer of HC Max™ Anti-fungal Ointment over affected area twice daily (morning and night) or as directed by a doctor. ■ Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. ■ For athlete’s foot pay special attention to spaces between the toes. ■ For athlete’s foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. ■ This product is not effective on the scalp or nails. ■ Supervise children in the use of this product.

Other information Store at controlled room temperature 15º-30º C (59º-86ºF) Do not permit to freeze.

Inactive ingredients  Methylparaben and white petrolatum.

HC MAX HONGO CURA (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT

label

HC MAX HONGO CURA 
zinc undecylenate undecylenic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-4628
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE20 g  in 100 g
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-4628-4228 g in 1 TUBE; Type 0: Not a Combination Product01/01/201712/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201712/08/2020
Labeler - Denison Pharmaceuticals, LLC. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC.001207208manufacture(0295-4628)

Revised: 12/2020
 
Denison Pharmaceuticals, LLC.