SOUNDBODY TOLNAFTATE ANTIFUNGAL- tolnaftate cream

SoundBody Tolnaftate Antifungal by

Drug Labeling and Warnings

SoundBody Tolnaftate Antifungal by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                             Purpose

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

PURPOSE

Uses

• proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• proven effective in the prevention of athlete's foot with daily use
• for effective relief of itching, burning and cracking

WARNINGS

For external use only

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

DO NOT USE

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night)
• supervise children in th euse of this product
• for athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change socks at least once a day
• use daily for 4 weeks; if condition persists longer, ask a doctor
• to prevent athlete's foot, apply twice daily (morning and/or night)
• this product is not effect on the scalp or nails

STORAGE AND HANDLING

Other information

• store between 20° to 25°C (68° to 77°F)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium phosphate dihydrate, propylene glycol, purified water, white petrolatum

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUNDBODY TOLNAFTATE ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-108
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
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
PARAFFIN (UNII: I9O0E3H2ZE)
MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: H3992158BT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-108-28	1 in 1 BOX	10/31/2016
1		28 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/26/2014

Labeler - United Exchange Corp. (840130579)