Sanafitil
FDA Label NDC 61357-149

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 61357-149). 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 - when using, otc - do not use, 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

  • For the treatment of most athlete's foot, jock itch & ringworm
  • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warning

  • For external use only.

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.
  • Not for diaper rash

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 and 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 (15°- 30°C)

Other Ingredients

petrolatum white, benzocaine, paraffin wax, salicylic acid, benzoic acid, boric acid, methyl salicylate, methyl paraben, propyl paraben, menthol crystals

Principal Display Panel - 28.35 G Tube Carton

SANAFITIL®
(Undecylenic Acid 10%)

ANTIFUNGAL

OINTMENT

1 OZ. (28.35g)

Principal Display Panel (28.35 g Tube Carton)

Principal Display Panel (28.35 g Tube Carton)

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