HC MAX HONGO CURA MS- undecylenic acid spray

HC Max Hongo Cura by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• 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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

STORAGE AND HANDLING

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

INGREDIENTS AND APPEARANCE

HC MAX HONGO CURA  MS
undecylenic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1032-12	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2017
2	NDC: 0295-1032-05	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2017	02/06/2019
3	NDC: 0295-1032-11	1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2017	02/06/2019
4	NDC: 0295-1032-16	3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2017	02/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2017

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-1032)