Active Ingredient
Zinc Pyrithione 1.0%
Balancing Shampoo
FDA Label NDC 73528-100
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 73528-100). 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, warnings, uses, directions, questions, inactive ingredients, 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
Purpose
Anti-Dandruff
Warnings
For external use only.
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
If condition worsens or does not improve after regular use of this product as directed, conult a doctor.
Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.
Do not use on children under 2 years of age, unless directed by a doctor.
Uses
For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.
Directions
Apply to wet hair and scalp. Massage to lather and let sit for 2-3 minutes. Rinse thoroughly. Repeat if desired.
For best results, use at least twice a week or as directed by a doctor.
For maximum dandruff control, use every time you shampoo.
Questions
1-877-No-Flake (1-877-663-5253)
Inactive Ingredients
Water (Aqua), Sodium Cocoyl Isethionate, Sodium Lauroamphoacetate, Acrylates Copolymer, Ethylhexyl Olivate, Stearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, Allium Sativum (Garlic) Bulb Extract, Pyrus Malus (Apple) Fruit Extract, Camellia Sinensis Leaf Extract, Panthenol, Citrus Reticulata (Tangerine) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Lavandula Angustifolia (Lavender) Oil, Mentha Aquatica Leaf Oil, Bertholletia Excelsa Seed Oil, Mentha Arvensis (Cornmint) Leaf Oil, Orbignya Oleifera Seed Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Vanillin, Cocos Nucifera (Coconut) Oil, Laminaria Saccharina Extract, Squalane, Caprylyl Glycol, Trimethylsiloxyamodimethicone, C11-15 Pareth-7, C12-16 Pareth-9, Trideceth-12, Yeast Ferment Extract, Decylene Glycol, Guar Hydroxypropyltrimonium Chloride, PEG-12 Dimethicone, Glycerin, Sodium Isethionate, Lactobacillus Ferment, Octenidine HCL, Sodium Polynaphthalenesulfonate, Xanthan Gum, Hexamidine Diisethionate, Ethylhexylglycerin
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
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