TOLNAFTATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)

Available from:

Morales Distributors, Inc.

INN (International Name):

TOLNAFTATE

Composition:

TOLNAFTATE 1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal - clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis) - helps prevent most athlete's foot from recurring when used daily - effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking - irritation occurs - there is no improvement within 4 weeks 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 - TOLNAFTATE CREAM
MORALES DISTRIBUTORS, 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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TOLNAFTATE 1 PERCENT
ACTIVE INGREDIENT (IN EACH GRAM)
Tolnaftate 1 percent
PURPOS E
Antifungal
US ES
clinically proven to cure most athlete's foot (tinea pedis) and
ringworm (tinea corporis)
helps prevent most athlete's foot from recurring when used daily
effectively soothes and relieves symptoms of athlete's foot, including
itching, burning and cracking
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 4 weeks
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
wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night)
supervise children in the use of this product
for athlete's foot, pay special attentional 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
night)
this product is not effective on the scalp or nails
OTHER INFORMATION
store between 2 degrees and 30 degrees Celsius (36 degrees and 86
degrees Fahrenheit)
INACTIVE INGREDIENTS
carbomer 940, cetyl alcohol, chlorocresol, dibasic sodium phosphate
hydrate, glycerin, glyceryl
monostearate, light liquid paraffin, purified water, and stearic acid
PACKAGE LABEL
NDC NO. 53210-1001-0
Tolnafate 1 percent
Cream USP 1 percent Antifungal
Relieves Itching and Burning
Cures and Prevents Athlete's Foot
Prevents and Relieves Itching and Redness
Anti-Itch Cream for Skin Irritations
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