Sanafitil
FDA Label NDC 61357-146

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zurich Medical Labs, Llc for the product Sanafitil (NDC 61357-146). 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 ingredients, purpose, uses, warning, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Undecylenic Acid 10%

Purpose

Antifungal

Uses

  • Cures most athlete's foot, jock itch & ringworm
  • Relieves itching, burning, cracking, and discomfort which accompany these conditions

Warning

  • For external use only.

Otc - Do Not Use

  • Not for diaper rash
    • Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Otc - When Using

  • When using this product avoid contact with eyes and mucous membrane.

Otc - Stop Use

Stop use and ask a doctor if:

  • Irritation occurs
  • There is no improvement within 4 weeks of treatment for athlete's foot and ringworm and 2 weeks of treatment for jock itch discontinue use and consult a doctor.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

In case of accidental ingestion seek professional assistance or contact a poison control center right away.

Directions

  • Clean affected area and dry thoroughly.
  • Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor.
  • For athlete's foot pay special attention to the space between the toes. Wear well fitting, ventilated shoes and change shoes & socks at least once a day.
  • For athlete's foot and ringworm, use daily for 4 weeks
  • For jock itch use daily for 2 weeks.
  • Supervise Children in use of this product.
  • Product not effective in the scalp or nails.

Other Information

Store at 59° - 86° F

Other Ingredients

isopropyl alcohol, purified water, benzocaine, salicylic acid, benzoic acid, methyl salicylate, boric acid, methyl paraben, mentol, propyl paraben, FD&C red #22.

Principal Display Panel - 30 Ml Bottle Carton

SANAFITIL®

ANTIFUNGAL
SOLUTION

• Relieves itching, burning, cracking, and
discomfort

1 OZ (30mL)

Principal Display Panel (30 mL Bottle Carton)

Principal Display Panel (30 mL Bottle Carton)

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