Dandruff
FDA Label NDC 46607-112

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ecocare for the product Dandruff (NDC 46607-112). 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 otc - active ingredient, purpose, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, dosage and administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                                                               Purpose

Zinc Pyrithione 0.95%..............................................................Anti-Dandruff

Purpose

Uses: Helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

FOR EXTERNAL USE ONLY

When Using This Product

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

Stop Use And Ask A Doctor If

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage And Administration

  • Shake well.
  • Wet hair thoroughly.
  • Massage a liberal quantity of shampoo evenly onto the scalp and rinse. Repeat and allow to remain on the scalp for a few minutes.
  • Rinse throroughly.
  • For best results use at least twice a week or as directed by a doctor.

Other Information

For external use only

Inactive Ingredients

Aqua (Deionized Water), Decyl Glucoside, Lauryl Glucoside, Coco Glucoside, Hydrolyzed Soy Protein, Guar Hydroxypropyltrimonium Chloride, Hydrolyzed Keratin, Tocopherol, Pantothenic Acid, Saccharomyces/Selenium Ferment, Calcium Chloride, Copper Gluconate, Potassium Chloride, Managanese Gluconate, Magnesium Gluconate, Zinc Gluconate, Sodium Chloride, Olea Europaea Fruit Oil, Myrtus Comunis Oil, Lavandula Angustifolia Oil, Thymus Vulgaris Oil, Rosmarinus Officinalis Leaf Oil, Prunus Armeniaca Kernal Oil, Eugenia Caryophyllus Flower Oil, Oryza Sativa Powder, Tapioca Starch, Carica Papayan Fruit, Yeast Extract, Rosmarinus Officinalis Leaf Powder, Salvia Officinalis Leaf Extract, Sucrose, Phenethyl Alcohol, Caprylyl Glycol, Citric Acid, Tetrasodium EDTA, Essential Oils Blend

Indications

Helps prevent recurrance of flaking and itching associated with dandruff.

Do Not Use

  • Condition worsens or does not improve after regular use of this product as directed.

Ask A Doctor

  • Condition worsens or does not improve after regular use of this product as directed.

Directions

  • Shake well.
  • Wet hair thoroughly.
  • Massage a liberal quantity of shampoo evenly onto the scalp and rinse. Repeat and allow to remain on the scalp for a few minutes.
  • Rinse thoroughly.
  • For best results use at least twice a week or as directed by a doctor.

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