SIGNATURE ATHLETES FOOT ANTIFUNGAL- tolnaftate powder

Signature Athletes Foot Antifungal by

Drug Labeling and Warnings

Signature Athletes Foot Antifungal by is a Otc medication manufactured, distributed, or labeled by Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlet's foot (tinea pedis) and ringworm (tinea corporis)
• helps prevent most athlete's foot with daily use
• for effective relief if itching, burning, cracking

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use

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

When using this product

• avoid contact with the eyes
• use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
• contents under pressure. Do not punture or incinerate. Do not store at temperature above 120°F (49°C).

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• for athlete's foot: pay special attention to spaces between the toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily
• use daily for 4 weeks; if condition persist longer, ask a doctor
• to prevent athlete's foot, apply once or twice daily (morning and/or night)
• this product is not effective on the scalp or nails
• in case of clogging, clean nozzle with pin

Other information

store at 20-25°C (68-77°F)

Inactive Ingredients

alcohol denat, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monoleate, stearalkonium hectorite, talc

Questions or comments?

1-800-719-9260

Package Labeling:

INGREDIENTS AND APPEARANCE

SIGNATURE ATHLETES FOOT ANTIFUNGAL 
tolnaftate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23667-814
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 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SORBITAN (UNII: 6O92ICV9RU)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23667-814-01	130 g in 1 CAN; Type 0: Not a Combination Product	01/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/21/2017

Labeler - Formulated Solutions, LLC (143266687)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	manufacture(23667-814)