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Product NDC Code | 55505-194 | ||||
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Drug Name | Hc max for jock itch |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 199126, 2106766 |
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Application Number | M005 | ||||
Labeler Name | Kramer Laboratories | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Tolnaftate 1% Anti-fungal
Tolnaftate 1% | Anti-fungal |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions ■ Clean the 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. ■ Supervise children in the use of this product. ■ For jock itch, use daily for 2 weeks. ■ If condition persists longer, consult a doctor. ■ This product is not effective on the scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Vera Leaf, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Dimethicone 350, Eucalyptol, Glyceryl Monostearate, Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water (USP), Sodium Hydroxide, Tea Tree Oil.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ Proven clinically effective in the treatment of most jock itch (tinea cruris). ■ For effective relief of itching, burning, or chafing associated with jock itch.
Purpose
Information about the drug product’s indications for use.Active Ingredient Purpose Tolnaftate 1% Anti-fungal
Tolnaftate 1% | Anti-fungal |
Spl product data elements
Usually a list of ingredients in a drug product.HC MAX FOR JOCK ITCH Tolnaftate Tolnaftate Tolnaftate Aloe Vera Leaf Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) Dimethicone 350 Eucalyptol Glyceryl Monostearate Lavender Oil Olive Oil Phenoxyethanol Poloxamer 188 Water Sodium Hydroxide Tea Tree Oil label carton
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL HC MAX™ Anti-Fungal Ointment Ungüento Anti-Hongos Tolnaftate 1% FOR JOCK ITCH Clinically Proven to CURE Most Jock Itch Probado Clínicamente para Curar La Mayoria de Casos de Tiña Inguinal plus Aloe & Tea Tree Oil for skin health CLINICALLY PROVEN INGREDIENT Relives ✓ Itching ✓ Burning ✓ Scaling ✓ Chafing Alivia ✓ Picazón ✓ Ardor ✓ Descamación ✓ Agrietamientó NET WT 1 OZ (28g) Probado Clínicamente para Curar La Mayoria de Casos de Tiña Inguinal más Aloe y aceite de árbol de té para la salud de la piel HC MAX™ Ungüento anti-hongos es infundido con 5 aceites naturales que incluyen árbol de té, eucalipto, aloe, oliva y lavanda. KRAMER LABORATORIES Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 kramerlabs.com funginail.com 1-800-824-4894 K0220 KRAMER LABORATORIES Kramer Laboratories, Inc. Bridgewater, NJ 08807 1-800-824-4894 Maximum Strength / Máxima Potencia HC MAX™ FOR JOCK ITCH Anti-Fungal Ointment / Ungüento Anti-Hongos Tolnaftate 1% NET CONTENT 1 OZ. (28 G) K0220
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on children under 2 years of age unless directed by a doctor.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-824-4894
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ■ Irritation occurs. ■ There is no improvement within 2 weeks.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ avoid contact with eyes.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at controlled room temperature 15°-30°C (59°-86°F) Do not permit to freeze.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API