Crystal Flush
FDA Label NDC 80569-184

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 80569-184). 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:, other 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

Undecylenic Acid 25%

Purpose

Anti-fungal

Uses:

For cure of most: 

  • ringworm (tinea corporis)
  • athlete's foot (tinea pedis).

    • For the relief of:

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation and discomforts which may accompany these conditions. 

Warnings:

For external use only.

  • Ask a doctor before use on children under two years of age. DO NOT USE on diaper rash.

    • When using this product avoid contact with eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within four weeks.

      • If pregnant or breast-feeding, 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 right away.

Directions:

  • Clean and dry affected area with soap and water and dry throughly.
  • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician.
  • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. For athlete's foot and ringworm. If Conditions persists for longer, consult a physician.
  • Intended for use typically by healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician.
  • This product is not meant to be applied directly to the Scalp or nails.

Other Ingredients:

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

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