Otc - Purpose
| Active ingredient | Purpose |
| Tolnaftate 1% | Anti-fungal |
Hc Max Anti-fungal Aerosol, Spray
FDA Label NDC 55505-195
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Hc Max Anti-fungal (NDC 55505-195). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Label (Label)
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