QUALITY CHOICE TOLNAFTATE ANTIFUNGAL- tolnaftate cream

Quality Choice Tolnaftate Antifungal by

Drug Labeling and Warnings

Quality Choice Tolnaftate Antifungal by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                  Purpose

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

PURPOSE

Uses

• clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• helps prevent most athlete's foot recurring when used daily
• effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet
  

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 space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one daily
• use daily for 4 weeks; if condition persists longer, ask a doctor
• for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks. If condition persists longer consult a doctor
• this product is not effective on the scalp or nails
  

STORAGE AND HANDLING

Other information

• store between 2° and 30° C (36° and 86° F)
• Lot No. and Exp. Date:see box or see crimp of tube
  

INACTIVE INGREDIENT

Inactive ingredients propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben

DOSAGE & ADMINISTRATION

Distributed By Quality Choice

Novi, Mi 48376-0995

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-104
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-104-46	1 in 1 CARTON	05/31/2013
1		30 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	05/31/2013

Labeler - Chain Drug Marketing Association Inc (011920774)