MICOCILEN ANTIFUNGAL- undecylenic acid liquid

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

Undecilenic Acid 25%

Purpose

Fungicida

Uses

For the cure of most

• ringworm (tinea corporis)
• athletes foot (tinea pedis)

Warnings

For external use only. If pregnant or breastfeeding consult a healthcare professional before use.

Do not use on children under 12 years of age unless directed by a Doctor. Avoid contact with eyes.

Use only as directed by a Doctor on persons with high sensitive skin.

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

Tea Tree Oil, Isopropyl Alcohol

PRINCIPAL DISPLAY PANEL - 29.5 ml Vial Carton

Arymar

Micocilen

Antifungal
Liquid

• Easy to Apply
• Dries Quickly, Non-Oily
  Formula

Net Cont. 1 Fl. Oz.
(29.5 ml)

Arymar

INGREDIENTS AND APPEARANCE

MICOCILEN   ANTIFUNGAL
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70570-0199
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N)	Undecylenic Acid	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Tea Tree Oil (UNII: VIF565UC2G)
Isopropyl Alcohol (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70570-0199-1	1 in 1 CARTON	03/01/2014
1		29.5 mL in 1 VIAL, GLASS; 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	03/01/2014

Labeler - Arymar Inc. (021650273)