FAMILY WELLNESS ANTIFUNGAL- tolnaftate 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

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

PURPOSE

Uses

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

WARNINGS

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 Poision Control Center right away.

INDICATIONS & USAGE

Directions

• wash affected area and dry thoroughlyapply 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 daily
• use daily for 4 weeks; if conditions persist longer, ask doctor
• to prevent athlete's foot, apply once or twice daily (morning and/or night)
• this product is not effective on the scalp or nails

STORAGE AND HANDLING

Other information

• store between 20°C to 25°C (68°F to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES INC.

10401 MONROE RD.

MATTHEWS, NC 28105 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-638
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
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: 55319-638-28	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)