Crystal Flush
FDA Label NDC 80569-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Triple Point Group, Llc for the product Crystal Flush (NDC 80569-101). 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 ingredient, purpose:, uses:, warnings:, otc - keep out of reach of children, directions:, inactive ingredients:, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Tolnaftate 1%

Purpose:

Anti-fungal

Uses:

Effective treatment for athlete's foot (tinea pedis) and ringworm (tinea corporis). For the effective relief of itching, scaling, cracking and discomforts which may accompany these conditions.

Warnings:

For external use only.

  • Avoid contact with the eyes.
  • Do not use on children under 2 years of age unless directed by a doctor.
    • If treating athlete's foot and ringworms: Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks.
    • If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Directions:

Clean or wash the affected area and dry throughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by doctor. For athletes foot, pay special attention to space 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. Supervise children in the use of this product.

Inactive Ingredients:

Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cymbopogan Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Azadirachta Indica (Neem) oil, Tocopheryl Acetate (Vitamin E).

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