FDA.reportPublic FDA data

Micotrin AC

Manufacturer
PureTek Corporation
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:22:35

Label at a glance#

ProductMicotrin AC
Active ingredientCLOTRIMAZOLE
Label structure7 sections

Indications and 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.

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Do not use

OTC - STOP USE SECTION

  • 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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Micotrin AC TM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN5
309367clotrimazole 10 MG/ML Topical CreamSCD5
309367clotrimazole 1 % Topical CreamSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-476-07Micotrin AC85 g in 1 TUBECREAM855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-476MICOTRIN AC (CLOTRIMAZOLE) CREAM [PURETEK CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241004_cbe4dd18-c9ef-a4e4-e053-2995a90a5289.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-476-07GM - Gram59088-4769c0634e3-402a-4315-a8a2-a2328bc85e8a12021-11-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-47659088-476-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
DIMETHICONE92RU3N3Y1OIACT
TEA TREE OILVIF565UC2GIACT
NEPIDERMINTZK30RF92WIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SOYBEAN OIL241ATL177AIACT
PANTHENOLWV9CM0O67ZIACT
CURDLAN6930DL209RIACT
SHEA BUTTERK49155WL9YIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
JOJOBA OIL724GKU717MIACT
PEG-40 STEARATEECU18C66Q7IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Micotrin ACCLOTRIMAZOLEPureTek Corporationcbe4dd18-c9ef-a4e4-e053-2995a90a52892024-10-01WarningsExact identifier
ndc (package): 59088-476-07
ndc (product): 59088-476
ndc11 (package): 59088047607
spl id: 23737455-6b67-0f15-e063-6394a90a215a
spl set id: cbe4dd18-c9ef-a4e4-e053-2995a90a5289

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.