Other
Drug Facts
Restoring Liquid
FDA Label NDC 73528-410
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zero Flakes Given, Inc. for the product Restoring (NDC 73528-410). 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 other, otc - active ingredient, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Otc - Purpose
| Active Ingredient | Purpose |
| Pyrithione Zinc 0.125% | Anti-Dandruff, Anti-seborrheic dermatitis |
Uses
Uses
For relief, and to help prevent reoccurance, of flaking and itching associated with dandruff and seborrheic dermatitis
Warnings
Warnings
For external use only
Otc - When Using
When using this product avoid contact with eyes. If contact occurs rinse eyes thoroughly with water
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed
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
Directions
Apply a thin layer across the scalp (dry or damp). Gently massage in and leave on. Repeat if desired up to four times a day.
Inactive Ingredient
Inactive Ingredients
Water, Aloe Barbadensis Leaf Juice, Propanediol, Glycerin, Gluconolactone, Sodium Polyacryloyldimethyl Taurate, Niacinamide, Salicylic Acid, Butylene Glycol, Sodium Benzoate, Xanthan Gum, Caprylic/Capric Triglyceride, Panthenol, Potassium Hydroxide,Pisum Sativum (Pea) Peptide, Punica Granatum Extract, Yeast Ferment Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Cetearamidoethyl Diethonium Succinoyl Hydrolyzed Pea Protein, Rosmarinus Officinalis (Rosemary) Leaf Extract, Propylene Glycol, Citric Acid, Potassium Sorbate, Raphanus Sativus (Radish) Root Extract, Leuconostoc/Radish Root Ferment Filtrate, 1,2-Hexanediol, Caprylyl Glycol, Sodium Polynaphthanlenesulfonate, Sodium Chloride, Camphor, Citrus Limon (Lemon) Peel Oil, Geranyl Acetate, Lavandula Oil/Extract, Limonene, Linalyl Acetate, Linalool, Mentha Piperita (Peppermint) Oil, Menthol, Terpineol, Vanillin, Lavandin Abrielis Oil, Illicium Verum (Anise) Fruit/Seed Oil, Dipropylene Glycol, Pentadecalactone, Geraniol, Hexyl Acetate, Ethyl Amyl Ketone, Salvia Officinalis (Sage) Oil, 3-Hexenol, Pinene
* Please review the disclaimer below.
