Sanafitil Talco
FDA Label NDC 61357-152

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 Talco (NDC 61357-152). 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, otc - purpose, uses, warning, otc - when using, otc - do not use, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Undecylenic Acid 2%Antifungal
Zinc Undecylenate 20%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.
  • Not for diaper rash

Otc - When Using

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

Otc - Do Not Use

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

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

talc

Principal Display Panel - 57 G Bottle Label

SANAFITIL®

ANTIFUNGAL
POWDER

  • Treats most Athlete's foot, Jock itch & Ringworm

    • NET WEIGHT / PESO
    NETO : 2 OZ (57 g)

    Principal Display Panel (57 g Bottle Label)

    Principal Display Panel (57 g Bottle Label)

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