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.
Updated October 11, 2022
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- Active Ingredient
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.
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
- Principal Display Panel
INGREDIENTS AND APPEARANCE
zinc pyrithione shampoo
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73528-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73528-100-01 280 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/01/2020 2 NDC:73528-100-02 85 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/01/2020 3 NDC:73528-100-03 9 mL in 1 PACKET; Type 0: Not a Combination Product 02/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 02/01/2020 Labeler - Zero Flakes Given, LLC. (116933871)