FUNGISOLVE TOLNAFTATE ANTIFUNGAL- tolnaftate liquid

FUNGISOLVE TOLNAFTATE ANTIFUNGAL by

Drug Labeling and Warnings

FUNGISOLVE TOLNAFTATE ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Tolnaftate 1%

Purpose

Antifungal

Uses

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

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

Warnings

For external use only use only as directed

Do not use

• children under 2 years of age unless directed by a doctor

When using this product

• avoid contact with the eyes or mouth
• use only as directed

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athelete's foot and ringworm) or 2 weeks (for jock itch)

Keep out of reach of children.

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

Directions

• wash the affected area and dry thoroughtly
• apply a thin layer over the affected area twice daily morning and night
• supervice 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.
• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if the condiotion persists longer, ask a doctor
• this product is not effective on scalp or nails

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

Butylated hydroxyanisole, DMDM Hyantoin, Ethoxydiglycol, Eucaliptu oil, Glycerin, Methyl Sallicylate, Pepermint oil, Polyethylene Glycol, Propylen glycol.

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)

INGREDIENTS AND APPEARANCE

FUNGISOLVE TOLNAFTATE ANTIFUNGAL 
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-106-01	30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	04/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/16/2011

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Dannso Corp./d.b.a. Essential Products		059741071	LABEL(70242-106)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(70242-106)