MICOCILEN- undecylenic acid cream 
Arymar Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Undecylenic Acid 15%

Purpose

Antifungal

Uses

Warnings

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

Other Information

Inactive ingredients

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

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

PRINCIPAL DISPLAY PANEL - 29.5 ml Tube Carton

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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
MICOCILEN 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70570-0198
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid150 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70570-0198-11 in 1 CARTON02/01/2015
129.5 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C02/01/2015
Labeler - Arymar Inc. (021650273)

Revised: 3/2019
Document Id: e8223098-366b-435b-ab44-e22d6a5dfe84
Set id: 4efa595c-0a90-4546-bb60-fa6ac12f3120
Version: 3
Effective Time: 20190304
 
Arymar Inc.