FAMILY WELLNESS ANTIFUNGAL- clotrimazole cream

Family Wellness Antifungal by

Drug Labeling and Warnings

Family Wellness Antifungal by is a Otc medication manufactured, distributed, or labeled by Family Dollar. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                 Purpose

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

PURPOSE

Uses

Relieves itching, burning, cracking, scaling, and discomfort

WARNINGS

Warnings

Do not use on children under 2 years of age except under the advice and supervision of 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 food and ringwood) or 2 weeks (for jock itch)
• do not use for diaper rash

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poision Control Center right away.

INDICATIONS & USAGE

Directions

• Wash affected area and dry thoroughly
• Apply a thick layer over affected area twice daily (morning and night) or as directed by a doctor
• 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 ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
• In condition persists longer, ask a doctor
• This product is no effective on the scalp or nails

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES INC.

10401 MONROE RD.

MATTHEWS, NC 28105 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS ANTIFUNGAL 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-626
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
2-OCTYLDODECYL PALMITATE (UNII: 6TBP0K24XM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETEARYL BEHENATE (UNII: 7ARI9LTH0U)
CETYL ESTERS WAX (UNII: D072FFP9GU)
MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: H3992158BT)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PEG-60 SORBITAN STEARATE (UNII: 073G38N8GC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-626-28	1 in 1 BOX
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/21/2014

Labeler - Family Dollar (024472631)