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Drug Facts
Mycozyl Ac Cream
FDA Label NDC 59088-441
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Mycozyl Ac (NDC 59088-441). 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 other, active ingredient, purpose, uses, warnings, otc - when using, do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Clotrimazole 1%
Purpose
Antifungal
Uses
■ For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
■ Relieves itching, burning, cracking, scaling, and discomfort which accompanies these conditions.
Warnings
For external use only.
Otc - When Using
When using this product avoid contact with eyes
Do Not Use
■ on children under 2 years of age unless directed by a doctor
■ for athlete's foot and ringworm - if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor
■ for jock itch - if irritation occurs or if there is no improvement in 2 weeks, discontinue use and consult 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.
Directions
■ Clean the affected area and dry thoroughly.
■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
■ 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.
■ For athlete's foot and ringworm, use daily for 4 weeks.
■ 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.
Use under the direction of a medical practitioner
Other Information
■ Store at 15° - 30°C (59° - 86°F) ■ avoid excessive heat ■ do not use if package is damaged
Inactive Ingredients
Aqua (Purified Water), Beta-Glucan, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetearyl Alcohol, Cetyl Alcohol, Dimethicone, Disodium EDTA, DL-Alpha-Tocopheryl Acetate, Ethyl Alcohol, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glycine Soja (Soybean) Oil, 1,2-Hexanediol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Panthenol, PEG-100 Stearate, PEG- 40 Stearate, PEG- 8, Polysorbate 60, Propylene Glycol, Sh- oligopeptide- 1, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide.
Mycozyl Ac Tm
Manufactured in the USA by:
PureTek Corporation
San Fernando, CA 91340
For questions or information
call toll-free:
1-877-921-7873
* Please review the disclaimer below.
