Trimazole Cream
FDA Label NDC 73352-570

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifluent Pharma Llc for the product Trimazole (NDC 73352-570). 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, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis).
  • Relieves itching, cracking, burning, and scaling, which accompany these conditions.

Warnings

For external use only

Otc - Do Not Use

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

Otc - Ask Doctor

Ask a doctor before use if you are using any other medicines or cleansers on your skin.

Otc - When Using

When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.

Otc - Stop Use

Stop use and ask a doctor 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).

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • Wash the affected area with soap and water and dry thoroughly.
  • Apply a thin layer of the product over the 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 spaces between 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.
  • Wash hands after each use.

Other Information

Store at 15-30°C (59-86°F). Avoid excessive heat.

Do not use if product is damaged.

Inactive Ingredients

Aloe barbadensis leaf extract, aminomethyl propanol, caprylic / capric triglyceride, cetyl alcohol, disodium EDTA, glyceryl stearate, hydroxypropylcellulose, Lavandula angustifolia (lavender) oil, Melaleuca alternifolia (tea tree) oil, methylparaben, PEG 100 stearate, polyethylene glycol 400, polysorbate 20, polysorbate 60, propylene glycol, propylparaben, purified water, stearic acid.

Questions/Comments?

(210) 944-6920

Principal Display Panel - 85 G Tube Pouch Label

Tear at notch to open. Do not use if seal is broken.

NDC 73352-570-01

TRIFLUENT
PHARMA™

Trimazole™

1% Clotrimazole

Topical Antifungal Cream

NET WT. 3 OZ. (85 G)

Principal Display Panel (85 G Tube Pouch Label)

Principal Display Panel (85 G Tube Pouch Label)

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