OTC Medication Information: Sanafitil

SANAFITIL- tolnaftate cream
Promex LLC

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.

Active Ingredients

Tolnaftate 1%

Purpose

Antifungal

Uses

  • clinically proven to cure most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevnet most athlete’s foot from recurring when used daily
  • effectively soothes and relieves symptoms of athlete’s foot, including itching, burning and cracking

Warnings

For external use only

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

Do not use

on children under 2 years of age except under the advice and supervision of a doctor

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot, pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete’s foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Inactive ingredients

Carbomer, Cetyl alcohol, Chlorocresol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

Principal Display Panel

Tolnaftate
(click image for full-size original)

Other Information

  • store between 36° and 86°F (2° and 30°C)

SANAFITIL
tolnaftate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58988-0017
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
GLYCERIN
GLYCERYL MONOSTEARATE
PARAFFIN
STEARIC ACID
WATER
CHLOROCRESOL
SODIUM PHOSPHATE, DIBASIC
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58988-0017-1 1 TUBE in 1 BOX contains a TUBE
1 28.35 g in 1 TUBE This package is contained within the BOX (58988-0017-1)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 01/07/2015
Labeler — Promex LLC (789974388)

Revised: 01/2015 Promex LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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