SANAFITIL CREMA- tolnaftate cream

Sanafitil Crema by

Drug Labeling and Warnings

Sanafitil Crema by is a Otc medication manufactured, distributed, or labeled by Promex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Other Information

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

INGREDIENTS AND APPEARANCE

SANAFITIL CREMA 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58988-1600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PARAFFIN (UNII: I9O0E3H2ZE)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
CHLOROCRESOL (UNII: 36W53O7109)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-1600-2	1 in 1 BOX
1		28.35 g in 1 TUBE

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)