Micotrin Ac™

Micotrin Ac™
SPL v5
SPL
SPL Set ID cbe4dd18-c9ef-a4e4-e053-2995a90a5289
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
Water 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-25

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 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.
  • his 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
Drug Facts

Drug Facts

Micotrin Ac Tm

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 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 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.
  • his 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
Drug Facts

Drug Facts

Micotrin Ac Tm (Micotrin AC TM)

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 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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