FDA Label for Curist Antifungal Relief

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT
PURPOSE
USES
WARNINGS
DO NOT USE
OTC - WHEN USING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
PRINCIPAL DISPLAY PANEL - 30 G TUBE CARTON

Curist Antifungal Relief Product Label

The following document was submitted to the FDA by the labeler of this product Little Pharma, Inc.. 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.

Other

Drug Facts

DISTRIBUTED BY:

Little Pharma, Inc.,

New York, NY 10023

Made in Canada

NDC: 72559-035-58

REV: 035-58-01

Active Ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis)
cures most jock itch (tinea cruris) and ringworm (tinea corporis)
relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do Not Use

on nails or scalp
in or near the mouth or the eyes
for vaginal yeast infections

Otc - When Using

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if too much irritation occurs or gets worse.

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.

Directions

adults and children 12 years and older:
- use the tip of the cap to break the seal and open the tube
- wash the affected skin with soap and water and dry completely before applying
- for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  - between the toes only:apply twice a day (morning and night) for 1 week or as directed by a doctor.
  - on the bottom or sides of the foot:apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
  - for jock itch and ringworm:apply once a day (morning ornight) for 1 week or as directed by a doctor.
  - wash hands after each use
  - children under 12 years: ask a doctor

1 week between the toes

Figure - terbinafine 01

2 weeks on the bottom or sides of the foot

Other Information

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.

store at controlled room temperature 20°to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol

Questions?

Call 1-844-243-1241 or email [email protected]

Principal Display Panel - 30 G Tube Carton

Curist

Antifungal Relief

Terbinafine Hydrochloride Cream 1%