EQUALINE TOLNAFTATE ANTIFUNGAL- tolnaftate cream

EQUALINE TOLNAFTATE ANTIFUNGAL by

Drug Labeling and Warnings

EQUALINE TOLNAFTATE ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC. 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), ringworm (tinea corporis)
• proven effective in the prevention of 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 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) 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 daily
• Use daily for 4 weeks; if condition persists longer, ask a 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 o to 25 oC (68 o to 77 oF)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

butylated hydroxytoluene, cetanol, ceteth-20, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearly alcohol

DOSAGE & ADMINISTRATION

DISTRIBUTED BY

SUPERVALU INC.

EDEN PRAIRIE,

MN 55344 USA

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUALINE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-251
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETETH-20 (UNII: I835H2IHHX)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-251-46	1 in 1 CARTON	09/28/2011
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41163-251-47	1 in 1 CARTON	09/28/2011
2		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	09/28/2011

Labeler - SUPERVALU INC (006961411)