PREMIER VALUE TOLNAFTATE ANTIFUNGAL- tolnaftate cream

PREMIER VALUE TOLNAFTATE ANTIFUNGAL by

Drug Labeling and Warnings

PREMIER VALUE TOLNAFTATE ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG CONSORTIUM, LLC. 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
• 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 spaces between the toes, wear well-fitting, ventilated shoes and change 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 condition persists longer consult a doctor
  
• This product is not effective on the scalp or nails
  

STORAGE AND HANDLING

Other Information

Lot No. and Exp. Date: see box or see crimp of the tube.  Store between 20o to 25oC (68o to 77oF)

INACTIVE INGREDIENT

Inactive Ingredients

Propylene glycol, liquid paraffin, stearyl alchol, cetyl alcohol, sorbitan monstearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben.

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

3301 N.W. BOCA RATON BLVD., SUITE 101

BOCA RATON, FL 33431

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

PREMIER VALUE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-014
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
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: 68016-014-79	1 in 1 CARTON
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	01/20/2012

Labeler - CHAIN DRUG CONSORTIUM, LLC (101668460)