FUNGISOLVE TOLNAFTATE ANTIFUNGAL- tolnaftate spray 
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 Spray

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

Flammable

Do not use while smoking or near heat or flame.

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other Information

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

Tamper evident do not accept if safety seal is broken or missing.

Inactive Ingredients

Aloe vera, alpha-tocopherol, franfrance, Isopropyl alcohol, Polyethylene Glycol, purified water, sodium m-bisulfite.

Questions or Comments?

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

Distributed by:

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

FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) SPRAY

Label Image
FUNGISOLVE TOLNAFTATE ANTIFUNGAL 
tolnaftate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70242-104-0144 mL in 1 BOTTLE, SPRAY; 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(70242-104)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(70242-104)

Revised: 4/2016
Document Id: fdad33d5-9435-4117-a52b-bf6ed67894af
Set id: 1931d22e-d708-4f80-b814-f4fb22fb6abd
Version: 1
Effective Time: 20160430
 
Dannso Corp./d.b.a. Essential Products