HC MAX ANTI-FUNGAL- tolnaftate aerosol, spray

HC Max Anti-Fungal by

Drug Labeling and Warnings

HC Max Anti-Fungal by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, American Spraytech, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• Tolnaftate 1%: Anti-fungal

INDICATIONS & USAGE

Uses ■ proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ prevents the recurrence of most athlete's foot with daily use ■ for effective relief of itching, cracking and burning

Warnings

For external use only.

WARNINGS

Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

WHEN USING

When using this product ■ avoid contact with eyes or mouth ■ use only as directed

STOP USE

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

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions ■ wash affected area and dry thoroughly ■ shake can well and spray a thin layer over affected area twice daily (morning and night) ■ 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 ■ use daily for 4 weeks ■ if condition persists, consult a doctor ■ to prevent athlete's foot, apply once or twice daily (morning and/or night) ■ This product is not effective on the scalp or nails.

STORAGE AND HANDLING

Other information store between 20º and 30º C (68º-86ºF) 

INACTIVE INGREDIENT

Inactive ingredients  BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B (36% w/w)

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Maximum Strength / Máxima Potencia

HC MAX™

Anti-Fungal Spray / Spray Anti-Hongos
Tolnaftate 1%

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

CLINICALLY PROVEN INGREDIENT

NET WT 5.3 OZ. (150 g)

KRAMER
LABORATORIES

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

INGREDIENTS AND APPEARANCE

HC MAX ANTI-FUNGAL 
tolnaftate aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	1.5 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Isobutane (UNII: BXR49TP611)
Ppg-12-Buteth-16 (UNII: 58CG7042J1)
Alcohol (UNII: 3K9958V90M)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-195-62	150 g in 1 CAN; Type 0: Not a Combination Product	05/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/28/2020

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
American Spraytech, LLC		137135237	manufacture(55505-195)