Fungisolve tolnaftate antifungal cream

Active ingredients

Tolnaftate 1%


Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)

can prevent recurrence of most athlete's foot

relieves sympotoms of athelete's foot including itching, burning, cracking and scaling.

Warnings

For external use only

Do not use

  • children under 2 years of age unless directed by a doctor
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

Stop use and ask a doctor if

too much irritation occurs or irratation gets worse

When using this product

avoid contact with the eyes or mouth. If eye contacts occurs, rinse eyes thoroughtly with water.

Keep out of reach of children.

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

Directions

  • adults and children 12 years and over
  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily morning and night
  • supervis 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 a day.

Other information

store between 20 to 25 C (68 to 77)F

do not accept if safety seal is torn broken or missing.

Inactive ingredients

Ceteareth-6, cety stearyl alcohol, methylparaben, mineral oil, PEG-20 cetyl/stearyl ether, propylene glycol, propylparaben, purified water, sodium m-bisulfite, stearyl alcohol.

Questions?

Call 305 2618762 M-F 9AM to 4PM Eastern Time

Distributed by:

Essential Productd Miami, FL, 33126 www.essentialproductsusa.com

Ingredients and appearance - Product information

Fungisolve tolnaftate antifungal cream- Tolnaftate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70242-107
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Tolnaftate ( UNII: 06KB629TKV)( Tolnaftate - UNII: 06KB629TKV ) 1 gin 100 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Mineral oil ( UNII: T5L8T28FGP)
Glycerin ( UNII: PDC6A3C0OX)
Peg-15 glyceryl stearate ( UNII: 91245SPD5K)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Stearic acid ( UNII: 4ELV7Z65AP)
Carbomer homopolymer type c (allyl pentaerythritol crosslinked) ( UNII: 4Q93RCW27E)
Myristoyl/palmitoyl oxostearamide/arachamide mea ( UNII: 1211AIM8G7)
Phosphate ion ( UNII: NK08V8K8HR)
Chlorocresol ( UNII: 36W53O7109)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 70242-107-05 14g in 1 TUBE 2016/04/30

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part333C USA 2016/04/30

Labeler - Dannso Corp./d.b.a. Essential Products( 059741071)

Establishment

Name ID/FEI Business Operations
Dannso Corp./d.b.a. Essential Products 059741071 LABEL( 70242-107)

Fungisolve tolnaftate antifungal (tolnaftate) cream