HEALTHY ACCENTS ANTIFUNGAL- clotrimazole cream

Healthy Accents Antifungal by

Drug Labeling and Warnings

Healthy Accents Antifungal by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                 Purpose

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

PURPOSE

Uses

• cures most athlete's 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

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

WHEN USING

When using this product avoid contact with eyes

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 chagne shoes and socks at least once daily
• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if condtion persists longer, ask a doctor
• this product is not effectiveo n the scalp or nails

STORAGE AND HANDLING

Other information store between 20° to 25° (68° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

benzyl alcohol, cetanol, liquid paraffin, octyldodecanol, polysorbate 60, propylene glycol, purified water, sodium hydroxide, sorbitan monostearate, stearic acid, stearyl alcohol

DOSAGE & ADMINISTRATION

Distributed by:

Salisbury, NC 28147

Scarborough, ME 04074

Product of Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTHY ACCENTS ANTIFUNGAL 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-829
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
PARAFFIN (UNII: I9O0E3H2ZE)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-829-28	1 in 1 CARTON	08/03/2016
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	07/26/2016

Labeler - DZA Brands LLC (090322194)