HC MAX FOR ATHLETES FOOT- tolnaftate ointment

HC Max For Athletes Foot by

Drug Labeling and Warnings

HC Max For Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories. 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. ■ To prevent athlete's foot, clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night). 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™

Anti-Fungal Ointment / Ungüento Anti-Hongos

FOR ATHLETE'S FOOT

Cures AND Prevents Most Athlete's Foot
Relives: ✓ Itching  ✓ Burning ✓ Cracking

Cura Y Previene La Mayoría de Casos De Pie De Atleta
Alivia:   ✓ Picazón ✓ Ardor    ✓ Agrietamiento

Maximum Strength / Máxima Potencia

HC MAX™ 
Tolnaftate 1%

plus
Aloe & Tea Tree Oil
for skin health

CLINICALLY PROVEN INGREDIENT

FOR ATHLETE'S FOOT

NET WT 1 OZ (28gm)

KRAMER
LABORATORIES

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

K1219  

Kramer Laboratories     Kramer Laboratories, Inc.     Bridgewater, NJ 08807     1-800-824-4894     K1219     

Maximum Strength / Máxima Potencia

HC MAX™ FOR ATHLETE'S FOOT

Anti-Fungal Ointment / Ungüento Anti-Hongos
Tolnaftate 1%

NET CONTENT 1 OZ. (28g)

INGREDIENTS AND APPEARANCE

HC MAX FOR ATHLETES FOOT 
tolnaftate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-203
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: 55505-203-26	1 in 1 CARTON	05/13/2020
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	05/13/2020

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmecuticals		001207208	manufacture(55505-203)