FUNGISOLVE TOLNAFTATE ANTIFUNGAL- tolnaftate cream 
Dannso Corp./d.b.a. Essential Products

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.

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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

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

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

FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM

Label Image
FUNGISOLVE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70242-108-0128 g in 1 TUBE; Type 0: Not a Combination Product04/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/16/2011
Labeler - Dannso Corp./d.b.a. Essential Products (059741071)
Registrant - Dannso Corp./d.b.a. Essential Products (059741071)
Establishment
NameAddressID/FEIBusiness Operations
Dannso Corp./d.b.a. Essential Products059741071LABEL(70242-108)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(70242-108)

Revised: 4/2016
Document Id: d4144fcc-20aa-446d-ad87-65104294be02
Set id: cc538c88-6887-4cb2-bd76-ec56cbd9b509
Version: 2
Effective Time: 20160430
 
Dannso Corp./d.b.a. Essential Products