Mycozyl Ac™

Mycozyl Ac™
SPL v5
SPL
SPL Set ID b676d257-3cfd-7f24-e053-2995a90a546e
Route
TOPICAL
Published
Effective Date 2021-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Dimethicone Tea Tree Oil Nepidermin Sodium Hydroxide Polyethylene Glycol 400 Soybean Oil Panthenol Curdlan Shea Butter Caprylyl Glycol Edetate Disodium Anhydrous .alpha.-tocopherol Acetate, Dl- Alcohol Glycerin Glyceryl Caprylate Glyceryl Monostearate 1,2-hexanediol Peg-100 Stearate Propylene Glycol Jojoba Oil Peg-40 Stearate Cetostearyl Alcohol Polysorbate 60 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-06

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

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.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product avoid contact with eyes

Warnings

For external use only.

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

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

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

Active Ingredient

Clotrimazole 1%

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, Dimethicone, Disodium EDTA, 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, Sholigopeptide-1, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, DL-alpha-tocopheryl acetate


Structured Label Content

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Purpose

Antifungal

Warnings

For external use only.

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

Do Not Use (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

Mycozyl Ac Tm (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

Active Ingredient (Active ingredient)

Clotrimazole 1%

Other Information (Other information)

■ Store at 15° - 30°C (59° - 86°F) ■ avoid excessive heat ■ do not use if package is damaged

Inactive Ingredients (Inactive ingredients)

Aqua (Purified Water), Beta-Glucan, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Disodium EDTA, 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, Sholigopeptide-1, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, DL-alpha-tocopheryl acetate


Advanced Ingredient Data


Raw Label Data

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