Label: BALANCING- zinc pyrithione shampoo

  • NDC Code(s): 73528-100-01, 73528-100-02, 73528-100-03
  • Packager: Zero Flakes Given, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 11, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Zinc Pyrithione 1.0%

  • 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

    Aqua (Water, Eau), 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 Nobilis (Mandarin Orange) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Lavandula Angustifolia (Lavender) Oil, Mentha Citrata Oil, Orbignya Oleifera Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Vanillin, Cocos Nucifera (Coconut) Oil, Laminaria Saccharina Extract, Squalane, Caprylyl Glycol, Yeast Ferment Extract, Guar Hydroxypropyltrimonium Chloride, Glycerin, Sodium Isethionate, Lactobacillus Ferment, Octenidine HCl, Sodium Polynaphthalenesulfonate, Xanthan Gum, Hexamidine Diisethionate, Ethylhexylglycerin, Coconut Alcohol, Raphanus Sativus (Radish) Root Extract, Arginine, Glycolic Acid, Polyquaternium-73, Pentylene Glycol, Propylene Glycol, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Citric Acid, Linalool

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • Principal Display Panel

    9ml Sachet280ml

  • INGREDIENTS AND APPEARANCE
    BALANCING 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73528-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73528-100-01280 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/01/2020
    2NDC:73528-100-0285 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/01/2020
    3NDC:73528-100-039 mL in 1 PACKET; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/01/2020
    Labeler - Zero Flakes Given, LLC. (116933871)