TOLNAFTATE D- tolnaftate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)

Available from:

NexMed (USA), Inc.

INN (International Name):

Tolnaftate

Composition:

Tolnaftate 1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal - 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 - Irritation occurs - There is no improvement within 2 weeks (for jock itch) and 4 weeks for (athlete’s foot and ringworm) on children under 2 years of age except under the advice and supervision of a doctor

Authorization status:

OTC monograph final

Summary of Product characteristics

TOLNAFTATE D- TOLNAFTATE CREAM
NEXMED (USA), INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
ACTIVE INGREDIENT
Tolnaftate
PURPOS E
Antifungal
US ES
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
For external use only
WHEN USING THIS PRODUCT
avoid contact with the eyes
STOP USE AND ASK A DOCTOR IF
Irritation occurs
There is no improvement within 2 weeks (for jock itch) and 4 weeks for
(athlete’s foot and
ringworm)
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
If swallowed, get medical help or contact a Poison Control Center
right away
DIRECTIONS
Clean the affected area and dry thoroughly
Apply a thin layer over affected area twice a daily (morning and
night) or as directed by a doctor
Supervise children in the use of this product
For athlete’s foot, pay 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
OTHER INFORMATION
Store between 20 and 25 C (68 to 77 F)
Lot No. and Exp. Date: see box or see crimp of tube
Keep box for complete instructions and labeling
INACTIVE INGREDIENTS
cetyl alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride,
methylparaben, mineral oil,
ceteth-10, propylene glycol, propylparaben, purified water, sorbitan
monostearate, stearyl alcohol
QUES TIONS ?
Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)
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