FUNGISOLVE TOLNAFTATE ANTIFUNGAL- tolnaftate cream

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)

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

FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM

INGREDIENTS AND APPEARANCE

FUNGISOLVE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-107
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-107-05	14 g in 1 TUBE; 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(70242-107)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(70242-107)