BALANCING- zinc pyrithione shampoo

Balancing by

Drug Labeling and Warnings

Balancing by is a Otc medication manufactured, distributed, or labeled by Zero Flakes Given, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

Principal Display Panel

INGREDIENTS AND APPEARANCE

BALANCING 
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 - No Flakes Given, LLC. (116933871)