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Drug Facts
Balancing Shampoo
FDA Label NDC 73528-110
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 Balancing (NDC 73528-110). 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 1% | Anti-Dandruff, Anti-Seborrhic Dermatitis |
Uses
Uses
For relief, and to help prevent reoccurance, of flaking and itching associated with dandruff and seborrhic 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
Wet hair, massage shampoo onto scalp. Rinse off after 2-3 minutes and repeat if desired. For best results, use at least twice a week or as directed by a doctor
Inactive Ingredient
Inactive Ingredients
Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Hydroxysultaine, Glycerin, Acrylates Copolymer, Glycolic Acid, Pisum Sativum (Pea) Peptide, Gluconolactone, Hydroxyethylcellulose, Sodium Chloride, Butylene Glycol, Sodium Benzoate, Potassium Sorbate, Squalane, Caprylic/Capric Triglyceride, Propylene Glycol, Raphanus Sativus (Radish) Root Extract, Punica Granatum Extract, Yeast Ferment Filtrate, Panthenol, Pyrus Malus (Apple) Fruit Extract, Potassium Hydroxide, Rosmarinus Officinalis (Rosemary) Leaf Extract, Leuconostoc/Radish Root Ferment Filtreate, Sodium Polynaphthalenesulfonate, Lactobacillus Ferment, Camellia Sinensis Leaf Extract, Allium Sativum (Garlic) Bulb Extract, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Leuconostoc Ferment Filtrate, Pentylene Glycol, Ethylhexylglycerin, Laminaria Saccharina Extract, Citric Acid, Polyquaternium-73, Arginine, Octenidine HCl, Camphor, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Limonene, Linalyl Acetate, Linalool, Mentha Piperita (Peppermint) Oil, Menthol, Terpineol, Vanillin, Lavandin Abrialis Oil, Illicium Verum Oil, Dipropylene Glycol, Pentadecalactone, Geraniol, Hexyl Acetate, Ethyl Amyl Ketone, Salvia Officnialis (Sage) Oil, 3-Hexenol
Otc - Questions
Questions?
1-877-NoFlake (1-877-663-5253)
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