HC MAX HONGO CURA- zinc undecylenate undecylenic acid ointment

HC Max Hongo Cura by

Drug Labeling and Warnings

HC Max Hongo Cura by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Denison Pharmecuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• Zinc Undecylenate 20%: Anti-fungal
• Undecylenic Acid 5%: Anti-fungal

INDICATIONS & USAGE

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

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

WHEN USING

When using this product ■ avoid contact with eyes.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Inactive ingredients  Methylparaben and white petrolatum.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HC Max™
MAXIMUM STRENGTH
Anti-Fungal Ointment

HONGO CURA

Proven Effective

Ungüento anti-hongos

✓ Cura la mayoría de casos de pie de atleta
✓ Alivia el ardor y la picazón

✓ Cures Most Athlete’s Foot
✓ Relieves Itching & Burning

No More Fungus!

NET CONTENT 1 OZ. (28gm)

KRAMER
LABORATORIES

Distributed by: Kramer Laboratories Inc. Coral Gables, FL 33134 1-800-824-4894

Certified
WBENC
Women's Business Certified

DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR NOT VISIBLE

K1217

Kramer Laboratories

Kramer Laboratories, Inc.      Coral Gables, FL 33134          1-800-824-4894          Hablamos español      

K1117

HC Max™
HONGO CURA

MAXIMUM STRENGTH

Ungüento Anti-hongos / Anti-fungal Ointment

Para el tratamiento del Pie de Atleta
For the Treatment of Most Athlete's Foot

NET CONTENT 1 OZ. (28gm)

INGREDIENTS AND APPEARANCE

HC MAX HONGO CURA 
zinc undecylenate undecylenic acid ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	ZINC UNDECYLENATE	20 g  in 100 g
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-181-26	1 in 1 CARTON	02/15/2017
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/13/2016

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmecuticals		001207208	manufacture(55505-181)