MICOCILEN- undecylenic acid cream

Micocilen by

Drug Labeling and Warnings

Micocilen by is a Otc medication manufactured, distributed, or labeled by Arymar Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Undecylenic Acid 15%

Purpose

Antifungal

Uses

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

Warnings

• For external use only

If pregnant or breast feeding consult a healthcare professional before use

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

When using this product avoid contact with the eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

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

Directions

• 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

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

Inactive ingredients

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

• 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)

INGREDIENTS AND APPEARANCE

MICOCILEN 
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70570-0198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N)	Undecylenic Acid	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Tricaprylin (UNII: 6P92858988)
Polysorbate 20 (UNII: 7T1F30V5YH)
Phenol (UNII: 339NCG44TV)
Salicylic Acid (UNII: O414PZ4LPZ)
Tea Tree Oil (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70570-0198-1	1 in 1 CARTON	02/01/2015
1		29.5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	02/01/2015

Labeler - Arymar Inc. (021650273)