Tineacide
FDA Label NDC 65373-500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Tineacide (NDC 65373-500). 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, inactive ingredients, uses, ask your physician, when using this product, warnings, tineacide label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Undecylenic Acid

Inactive Ingredients

Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, Lavender Oil, Methylparaben, PEG-100, Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water

Uses

Cures Athlete's Foot (tinea pedis) jock itch (tinea cruris) and ringworm (tinea corporis).

For effective relief of itching, cracking, burning and discomfort which can accompany these conditions.

Ask Your Physician

Do not use on children under 2 years of age unless directed by a physician

When Using This Product

Wash the affected area with soap and water and dry thoroughly.  Apply sparingly over affected area twice daily (morning and night) or as directed by a physician.  For athlete's foot pay special attention to 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 physician.

Warnings

For external use only.  Avoid contact with eyes.  If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch) discontinue use and consult a physician.  Keep this and all drugs out of the reach of children.  In case of accidental ingestion seek professional assistance or contact a poison control center immediately.

Tineacide Label

Tineacide Antifungal Cream  Physician Formula
Dispensed by a physician only.
1.25 Ounce Label (Blaine Tineacide Antifungal Cr)

1.25 Ounce Label (Blaine Tineacide Antifungal Cr)


1.25 Ounce Label (Physician Formula)

1.25 Ounce Label (Physician Formula)




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