Neoketramin Antifungal Dandruff Seborrheic Dermatitis Psoriasis Treatment Liquid
FDA Label NDC 83004-019

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Neoketramin Antifungal Dandruff Seborrheic Dermatitis Psoriasis Treatment (NDC 83004-019). 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, directions, other information, warnings, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Salicylic Acid 3%

Purpose

Psoriasis Dandruff
Seborrheic Dermatitis

Uses

Relieves and helps prevent recurrence of scalp:

  • irritation
  • itching
  • redness
  • flaking
  • scaling due to psoriasis and seborrheic dermatitis

Directions

 Adults and children aged 12 and over
  •  wet hair thoroughly
  • Apply shampoo, generously lather, then rinse thoroughly. Repeate
  • Use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control 
    • dandruff
 Children under 12 years old.                  Ask a doctor

Other Information

  • Store between 20°-25° C (68° -77° F)
  • See bottom panel for lot number and expiration date.

Warnings

For external use only
Do not use

  • On damaged or inflamed scalp
  • If you are allergic to ingredients in this product

    • When using this product

    • Avoid contact with eyes
    • If contact occurs, rinse the eyes thoroughly with water.

      • Stop use and ask a doctor if:

      • Rash appears
      • Condition worsen or does not improve in 2-4 weeks.

        • If pregnant or breast-feeding, ask a doctor before use.

        Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Ascorbic Acid, Cocamidopropyl Betaine, DL Panthenol USP Powder, Green Tea Extract, Linolemidopropyl PG-Dimonium Chloride Phosphate, PEG-120 Methyl Glucose Dioleate, Polyquaternium-7, Propylene Glycol, Puried Water, Sodium C-14-16 Olefin Sulfonate, Tea Tree Oil, Trolamine, Vitamin E Acetate

Product Label

Image Description (Label)

Image Description (Label)

* Please review the disclaimer below.