QUINSANA ATHLETES FOOT ANTI FUNGAL- tolnaftate powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Profoot, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) - Effectively relieves itching, cracking, and burning

Authorization status:

OTC monograph final

Summary of Product characteristics

QUINSANA ATHLETES FOOT ANTI FUNGAL- TOLNAFTATE POWDER
PROFOOT, 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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QUINSANA ATHLETE'S FOOT ANTI-FUNGAL POWDER
_DRUG FACTS_
_ACTIVE INGREDIENT_
Tolnaftate, 1%
PURPOS E
Antifungal
_USES_
Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and
ringworm (tinea corporis)
Effectively relieves itching, cracking, and burning
_WARNINGS_
FOR EXTERNAL USE ONLY
ASK A DOCTOR BEFORE USE
on children under 2 years of age
WHEN USING THIS PRODUCT
avoid contact with eyes
STOP USE AND ASK A DOCTOR IF
irritation occurs
there is no improvement within 4 weeks (for athlete's foot and
ringworm) or 2 weeks (for jock itch)
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 of the product over time indicated.
Supervise children in the use of this product. FOR ATHLETE'S FOOT AND
RINGWORM:
Use twice daily
(morning and night) for 4 weeks or as directed by physician. Pay
special attention to spaces between
the toes. Wear well-fitting, ventilated shoes, and change shoes and
socks at least once daily.
FOR
JOCK ITCH:
Use daily for 2 weeks.
Clean the affected area and dry thoroughly.
This product is not effective on the scalp or nails.
_INACTIVE INGREDIENTS_
Talc, Cornstarch.
PACKAGE LABELING:
QUINSANA ATHLETES FOOT ANTI FUNGAL
tolnaftate powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:29 78 4-141
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TO LNAFTATE (UNII: 0 6 KB6 29 TKV) (TOLNAFTATE - UNII:0 6 KB6 29 TKV)
TOLNAFTATE
10 mg in 1 g
Profoot, Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
TALC (UNII: 7SEV7J4R1U)
STARCH, CO RN (UNII: O8 232NY3SJ)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MA