Sunmark™

Sunmark™
SPL v9
SPL
SPL Set ID 6f85fbb0-297c-4949-83f2-ed9a52172154
Route
TOPICAL
Published
Effective Date 2023-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Butylated Hydroxytoluene Polyethylene Glycol 400 Polyethylene Glycol 3350 Titanium Dioxide Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-02-17

Description

Drug Facts

Purpose

Antifungal

How Supplied

Product: 50090-3358 NDC: 50090-3358-0 15 g in a TUBE / 1 in a CARTON


Medication Information

Purpose

Antifungal

How Supplied

Product: 50090-3358

NDC: 50090-3358-0 15 g in a TUBE / 1 in a CARTON

Description

Drug Facts

Uses
  • clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) 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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

For external use only

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
  • this product is not effective on scalp or nails
Tolnaftate
Active Ingredient

Tolnaftate 1%

Other Information
  • Store between 15° - 30°C (59° - 86°F)
  • See end panel of carton and tube crimp for lot number and expiration date
For Athlete's Foot
  • pay special attention to spaces between toes
  • wear well-fitting shoes, change shoes and socks at least once daily
Inactive Ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

Structured Label Content

Uses
  • clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) 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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50570-1 (50570-1)

For external use only

Purpose

Antifungal

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
  • this product is not effective on scalp or nails
Tolnaftate
How Supplied (HOW SUPPLIED)

Product: 50090-3358

NDC: 50090-3358-0 15 g in a TUBE / 1 in a CARTON

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)
  • Store between 15° - 30°C (59° - 86°F)
  • See end panel of carton and tube crimp for lot number and expiration date
For Athlete's Foot (For athlete's foot)
  • pay special attention to spaces between toes
  • wear well-fitting shoes, change shoes and socks at least once daily
Inactive Ingredients (Inactive ingredients)

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)