Mycozyl Al™

Mycozyl Al™
SPL v3
SPL
SPL Set ID b82c9a8a-f6f1-dca6-e053-2995a90a47f9
Route
TOPICAL
Published
Effective Date 2021-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.3 g)
Inactive Ingredients
Argan Oil Benzyl Alcohol .alpha.-tocopherol Acetate, Dl- Dimethyl Sulfoxide Eucalyptus Oil Glycerin Laureth-4 Lavender Oil Tea Tree Oil Polyethylene Glycol 400 Apple Cider Vinegar

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-09

Description

Tolnaftate 1%

Purpose

Antifungal

How Supplied

Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)


Medication Information

Purpose

Antifungal

How Supplied

Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)

Description

Tolnaftate 1%

Uses

■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).

■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.

■ for the prevention of most Athlete’s foot with daily use.

■ eliminates fungus on fingers, toes, and around the nails.

■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.

Warnings

For external use only

Directions

■ clean the affected area and dry thoroughly

■ apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails 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

■ if condition persists longer, consult a doctor.

Use under the direction of a medical practitioner

Do Not Use On

children under 2 years of age unless directed by a doctor.

Mycozyl Al™

Manufactured in the USA by:

PureTek Corporation

San Fernando, CA 91340

For questions or information

call toll-free: 877-921-7873

Active Ingredient

Tolnaftate 1%

Other Information

■ Store at 15 - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

■ avoid excessive heat

■ do not use if package is damaged

Inactive Ingredients

Apple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

When Using This Product

■ do not get into eyes

Stop Use and Ask A Doctor

■ for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks

■ for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).

■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.

■ for the prevention of most Athlete’s foot with daily use.

■ eliminates fungus on fingers, toes, and around the nails.

■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.

Purpose

Antifungal

Warnings

For external use only

Directions

■ clean the affected area and dry thoroughly

■ apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails 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

■ if condition persists longer, consult a doctor.

Use under the direction of a medical practitioner

How Supplied

Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)

Do Not Use On (Do not use on)

children under 2 years of age unless directed by a doctor.

Mycozyl Al™ (Mycozyl AL™)

Manufactured in the USA by:

PureTek Corporation

San Fernando, CA 91340

For questions or information

call toll-free: 877-921-7873

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)

■ Store at 15 - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

■ avoid excessive heat

■ do not use if package is damaged

Inactive Ingredients (Inactive ingredients)

Apple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

When Using This Product (When using this product)

■ do not get into eyes

Stop Use and Ask A Doctor (Stop use and ask a doctor)

■ for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks

■ for prevention of athlete’s foot - if irritation occurs, discontinue use and consult 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.


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