Micocilen

Manufacturer: Arymar Inc.
Effective date: 2019-03-04
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:58:43

Label at a glance#

ProductMicocilen

Active ingredientUndecylenic Acid

Label structure10 sections

Indications and uses

proven clinically effective in the treatment of most athletes foot (linea pedis) and ringworm (linea corporis)

Dosage and administration

wash 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

Storage and handling

Keep tightly closed when not in use Store away from excessive heat and cold

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 15%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

proven clinically effective in the treatment of most athletes foot (linea pedis) and ringworm (linea corporis)

Warnings

WARNINGS SECTION

For external use only

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding consult a healthcare professional before use

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under advice and supervision of a doctor

Use only as directed by a doctor on persons with highly sensitive skin

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs
there is no improvement within 4 weeks

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

wash 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

Other Information

STORAGE AND HANDLING SECTION

Keep tightly closed when not in use
Store away from excessive heat and cold

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Cetyl Alcohol, Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Glycerl Monostearate, Caprylic Triglyceride, Polysorbate 20, Phenol, Salicylic Acid, Tea Tree Oil.

SPL UNCLASSIFIED SECTION

Distributed by: Arymar Inc.
8004 NW 154 St. #343 Miami Lakes FL 33016

PRINCIPAL DISPLAY PANEL - 29.5 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dries Quickly, Non-Oily Formula
Easy to Apply

Micocilen

Antifungal
Cream

Cures & Prevents Most Athlete's Foot
Relieves Itching and Burning

Net Cont. 1 Fl. Oz (29.5 ml)

PRINCIPAL DISPLAY PANEL - 29.5 ml Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1792394	undecylenic acid 15 % Topical Cream	PSN	3
1792394	undecylenic acid 150 MG/ML Topical Cream	SCD	3
1792394	undecylenic acid 15 % Topical Cream	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70570-0198-1	2021-01-29	C162847	48780-1	ba0f9c33-4d18-a910-e053-dadaa90a0b85	Micocilen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70570-0198-1	Micocilen	1 in 1 CARTON	CREAM	1		3
70570-0198-1	Micocilen	29.5 mL in 1 TUBE	CREAM	29.5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70570-0198	MICOCILEN (UNDECYLENIC ACID) CREAM [ARYMAR INC.]	3	Legacy NDC, 2 package rows	20190307_4efa595c-0a90-4546-bb60-fa6ac12f3120.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Micocilen
Undecylenic Acid
Water
Cetyl Alcohol
Glyceryl Monostearate
Tricaprylin
Polysorbate 20
Phenol
Salicylic Acid
Tea Tree Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70570-0198	70570-0198-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Undecylenic Acid	K3D86KJ24N	ACTIB
Water	059QF0KO0R	IACT
Cetyl Alcohol	936JST6JCN	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
Tricaprylin	6P92858988	IACT
Polysorbate 20	7T1F30V5YH	IACT
Phenol	339NCG44TV	IACT
Salicylic Acid	O414PZ4LPZ	IACT
Tea Tree Oil	VIF565UC2G	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e8223098-366b-435b-ab44-e22d6a5dfe84			4efa595c-0a90-4546-bb60-fa6ac12f3120	2019-03-04	Warnings	Exact identifier spl id: e8223098-366b-435b-ab44-e22d6a5dfe84 spl set id: 4efa595c-0a90-4546-bb60-fa6ac12f3120

Reported adverse events (FAERS/openFDA)#

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