BALANCING- zinc pyrithione shampoo 
Zero Flakes Given, LLC.

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.

----------

Balancing Shampoo

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.

Principal Display Panel

9ml Sachet280ml

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)

Revised: 10/2022
Document Id: eacc0b70-1a69-ca6a-e053-2995a90afd2b
Set id: 984780fd-4969-150b-e053-2995a90aed77
Version: 4
Effective Time: 20221011
 
Zero Flakes Given, LLC.