Fifthpulse Clotrimazole Antifungal Ointment
FDA Label NDC 87525-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wecare Products Llc for the product Fifthpulse Clotrimazole Antifungal (NDC 87525-002). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Clotrimazole USP 1% w/w

Purpose

Antifungal

Uses

  • Cures athlete's foot (tine pedis) , jock itch (tines 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 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 This And All Drugs 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 athelete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and changes shoes and socks at least once daily.
  • For athelete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 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° to 30° C (59° to 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.Mineral oil, Petrolatum

Questions Or Comments?

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