SOUNDBODY CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream

SoundBody Clotrimazole Antifungal by

Drug Labeling and Warnings

SoundBody Clotrimazole 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 ingredients                          Purpose

Clotrimazole 1%.......................... Antifungal

PURPOSE

Uses

• Cures most athletes foot, jock itch, and ringworm
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

WARNINGS

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

STOP USE

Stop use and ask a doctor if

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

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 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 ringwom use daily for 4 weeks; for jock itch; use daily for 2 weeks
• this product is not effective 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

2-octyldodecanol, benzyl alcohol, cetostearyl alcohol, cetyl esters, monobasic sodium phosphate dihydrate, polysorbate 60, propylene glycol, purified water, sorbitan stearate

SPL UNCLASSIFIED SECTION

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUNDBODY CLOTRIMAZOLE ANTIFUNGAL 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: H3992158BT)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-139-28	1 in 1 BOX	10/04/2016
1		28 g in 1 TUBE; 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)