X-folate
FDA Label NDC 59279-516

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mediceutical Laboratories, Ltd for the product X-folate (NDC 59279-516). 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

5% coal tar soluble extract

Purpose

anti-dandruff, anti-psoriasis, anti-seborrheic dermatitis

Uses

Helps control and prevent flaking & itching associated with dandruff and seborrheic dermatitis.

Warnings

For external use only. If condition worsens or does not improve after regular use of this products as directed, discontinue a nd consult a physician. If condition covers large area of the body, consult your physician before using this product.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a poision control center right away. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

Directions

For best results use daily or until condition is under control or as directed by a physician. For maximum control use every time you shampoo.

  • Apply shampoo to wet hair, massage into hair and scalp, leave on for 2-3 minutes.
  • Thoroughly rinse and repeat if desired.
  • Apply Therapeutic scalp and hair treatment rinse for 2-3 minutes, thoroughly rinse.


    • Consult your salon professional for additional Mediceuticals scalp and hair treatments specifically tailored for your condition.

Inactive Ingredients

Benzophenone-4, Caprylyl Glycol, Cocamidopropyl Betaine, Dicetyldimonium Chloride, Ethylhexyl Methoxycinnamate, Fragrance (Parfum), Hexylene Glycol, Magnesium Chloride, Menthol, Octocrylene, Olea Europea (Olive) Fruit Oil, Panthenol, Phenoxyethanol, Polyquaternium-7, Polyquaternium-10, Polysorbate 80, Salicylic Acid, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua).

Package Label.Principal Display Panel

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