Micocilen
FDA Label NDC 70570-0198

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Arymar Inc. for the product Micocilen (NDC 70570-0198). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - pregnancy or breast feeding, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding consult a healthcare professional before use

Otc - Do Not 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

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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.

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)

    Principal Display Panel (29.5 ml Tube Carton)

    Principal Display Panel (29.5 ml Tube Carton)

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