FDA Label for Premier Value Tolnaftate Antifungal
View Indications, Usage & Precautions
Premier Value Tolnaftate Antifungal Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient Purpose
Tolnaftate 1%
.................................................................................Antifungal
Otc - 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
Otc - When Using
When using this product avoid contact with the eyes.
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
Otc - Do Not Use
Do not use on children under 2 years of age except under the
advice and supervision of a doctor.
Otc - 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
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