XTRACARE ANTIFUNGAL FOOT- tolnaftate spray

XtraCare Antifungal Foot by

Drug Labeling and Warnings

XtraCare Antifungal Foot by is a Otc medication manufactured, distributed, or labeled by Rejoice International, Zhejiang Ludao Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient  ............................................ Purpose

Tolnaftate 1% .................................................. Antifungal

PURPOSE

Use

• cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• if used daily, can prevent recurrence of athlete's foot
• relieves symptoms of athlete's foot, including itching, burning and cracking

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

INDICATIONS & USAGE

XtraCare® Antifungal Foot Spray

For Athlete's Foot

Tolnaftate 1%

• Relieves Itching & Burning
• Cures & Prevents Most Athlete's Foot
• Fights Odor All Day

*Compare to the Active Ingredient in Tinactin®

CAUTION  Contents under pressure - Read precautions on back panel.

Net Wt 3.5 Oz (100g)

WARNINGS

Warnings

For external use only.

Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120oF (49oC).

When using this product

• avoid eyes & face
• use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement after 4 weeks

DOSAGE & ADMINISTRATION

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 betwen the toes; wear well-fitted, ventilated shoes and change shoes and socks at least once a day.
• use daily for 4 weeks; if condition persists longer, consult a doctor
• to prevent athlete's foot, apply once or twice daily (morning and night)
• in case of clogging, clean nozzle with a pin

INACTIVE INGREDIENT

Inactive Ingredients

butane, propane, alcohol, butylated hydroxytoluene, talc.

OTHER SAFETY INFORMATION

Other information store between 68o to 77oF (20o to 25oC)

Questions/Comments? 1-855-345-5575

*This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Tinactin®

DISTRIBUTED BY

REJOICE INTERNATIONAL, INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE ANTIFUNGAL FOOT 
tolnaftate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-056
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
BUTANE (UNII: 6LV4FOR43R)
PROPANE (UNII: T75W9911L6)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-056-01	100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/11/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/11/2014

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ludao Cosmetics Co., Ltd.		679885595	manufacture(57337-056)