HC MAX HONGO CURA- tolnaftate 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
• Tolnaftate 1%: Anti-fungal

INDICATIONS & USAGE

Uses ■ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis). ■ Helps prevent most athlete's foot with daily use. ■ 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. ■ For toe fungus, apply under nail and around cuticle area. 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  
Purified Water USP, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Phenoxyethanol, Dimethicone 350, Glyceryl Monostearate, Poloxamer 188, Aloe Vera Leaf, Eucalyptol, Lavender Oil, Olive Oil, Tea Tree Oil, Sodium Hydroxide.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Maximum Strength / Máxima Potencia

HC Max™

HONGO CURA
Anti-Fungal Ointment
FOR
ATHLETE'S FOOT

Cures AND Prevents Most Athlete's Foot
Cura Y Previene La Mayoría de Casos De Pie De Atleta

Relives: ✓ Itching  ✓ Burning ✓ Cracking
Alivia:   ✓ Picazón ✓ Ardor    ✓ Agrietamiento

NET WT 1 OZ. (28gm)

K0719

KRAMER
LABORATORIES

Distributed by: Kramer Laboratories Inc. Bridgewater, NJ 08807 1-800-824-4894

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

Kramer Laboratories

Kramer Laboratories, Inc.     Bridgewater, NJ 08807          1-800-824-4894          Hablamos español      

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)

K1118

INGREDIENTS AND APPEARANCE

HC MAX HONGO CURA 
tolnaftate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)
Phenoxyethanol (UNII: HIE492ZZ3T)
Dimethicone 350 (UNII: 2Y53S6ATLU)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Poloxamer 188 (UNII: LQA7B6G8JG)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Eucalyptol (UNII: RV6J6604TK)
Lavender Oil (UNII: ZBP1YXW0H8)
Olive Oil (UNII: 6UYK2W1W1E)
Tea Tree Oil (UNII: VIF565UC2G)
Sodium Hydroxide (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-186-26	1 in 1 CARTON	11/15/2018
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	11/15/2018

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmecuticals		001207208	manufacture(55505-186)