FDA Label for Hc Max Anti-fungal

View Indications, Usage & Precautions

Hc Max Anti-fungal Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



Active ingredientPurpose
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.

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.


Otc - When Using



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


Otc - Stop Use



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


Otc - Do Not Use



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


Otc - 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 20° and 30° C (68°-86°F) 


Inactive Ingredient



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


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


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