Mycozyl AC

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Mycozyl AC
Generic name: CLOTRIMAZOLE
Manufacturer: PureTek Corporation
Product type: HUMAN OTC DRUG
SPL set ID: b676d257-3cfd-7f24-e053-2995a90a546e
SPL ID: 23740ac5-b214-253d-e063-6394a90a1951
Version: 5
Effective date: 2024-10-01
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:52:26

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		Mycozyl AC	openfda.brand_name
generic name		CLOTRIMAZOLE	openfda.generic_name
manufacturer name		PureTek Corporation	openfda.manufacturer_name
ndc	package	59088-441-07	openfda.package_ndc
ndc	product	59088-441	openfda.product_ndc
ndc11	package	59088044107	derived:openfda.package_ndc
rxcui		309367	openfda.rxcui
spl id		23740ac5-b214-253d-e063-6394a90a1951	id
spl set id		b676d257-3cfd-7f24-e053-2995a90a546e	set_id
unii		G07GZ97H65	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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

Reported adverse events (FAERS/openFDA)#

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