Tm-clotrimazole Cream
FDA Label NDC 83035-1062

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Singular Dreamer, Ltd Dba True Marker for the product Tm-clotrimazole (NDC 83035-1062). 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 active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Clotrimazole USP 1% w/w

Purpose

Antifungal

Uses

  • Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

  • For external use only
  • Do Not Use – On children under 2 years of age unless directed by a doctor.
  • 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 or ringworm) or within 2 weeks (for jock itch).
  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions

  • Wash the affected area and dry thoroughly.
  • Apply a thin layer over affected area twice daily (morning and night), or as directed by a doctor.
  • Supervise children in the use of this product.
  • For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
  • 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.
  • This product is not effective on the scalp or nails.

Other Information

  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Close cap tightly after use.

Inactive Ingredients

Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides,Petrolatum, Polyoxyethylene lauryl ether, Purified water.

Questions?

304-742-2433

Product Label

Image Description (Image 1)

Image Description (Image 1)

* Please review the disclaimer below.