Sunmark Cream
FDA Label NDC 49348-155

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Sunmark (NDC 49348-155). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - do not use, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Distributed by McKesson
One Post Street
San Francisco, CA 94104

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

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

Otc - Do Not Use

For external use only

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Otc - When Using

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 (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

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

  • 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

For Athlete's Foot

  • pay special attention to spaces between toes
  • wear well-fitting shoes, change shoes and socks at least once daily

Other Information

  • Store between 15° - 30°C (59° - 86°F)
  • See end panel of carton and tube crimp for lot number and expiration date

Inactive Ingredients

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

Principal Display Panel - 15 G Tube Carton

sunmark™

antifungal cream

Tolnaftate 1%
CURES & PREVENTS MOST ATHLETE'S FOOT

NET WT 0.5 OZ (15 g)

Principal Display Panel (15 g Tube Carton)

Principal Display Panel (15 g Tube Carton)

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