Balancing Shampoo (V2) (73528-110)

Manufacturer
Zero Flakes Given, Inc.
Effective date
2026-04-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:18

Label at a glance#

ProductBalancing
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Indications and uses

Uses For relief, and to help prevent reoccurance, of flaking and itching associated with dandruff and seborrhic dermatitis

Dosage and administration

Wet hair, massage shampoo onto scalp. Rinse off after 2-3 minutes and repeat if desired. For best results, use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

OTC - PURPOSE SECTION

Active IngredientPurpose
Pyrithione Zinc 1%Anti-Dandruff, Anti-Seborrhic Dermatitis

Uses

INDICATIONS & USAGE SECTION

Uses

For relief, and to help prevent reoccurance, of flaking and itching associated with dandruff and seborrhic dermatitis

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hair, massage shampoo onto scalp. Rinse off after 2-3 minutes and repeat if desired. For best results, use at least twice a week or as directed by a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Hydroxysultaine, Glycerin, Acrylates Copolymer, Glycolic Acid, Pisum Sativum (Pea) Peptide, Gluconolactone, Hydroxyethylcellulose, Sodium Chloride, Butylene Glycol, Sodium Benzoate, Potassium Sorbate, Squalane, Caprylic/Capric Triglyceride, Propylene Glycol, Raphanus Sativus (Radish) Root Extract, Punica Granatum Extract, Yeast Ferment Filtrate, Panthenol, Pyrus Malus (Apple) Fruit Extract, Potassium Hydroxide, Rosmarinus Officinalis (Rosemary) Leaf Extract, Leuconostoc/Radish Root Ferment Filtreate, Sodium Polynaphthalenesulfonate, Lactobacillus Ferment, Camellia Sinensis Leaf Extract, Allium Sativum (Garlic) Bulb Extract, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Leuconostoc Ferment Filtrate, Pentylene Glycol, Ethylhexylglycerin, Laminaria Saccharina Extract, Citric Acid, Polyquaternium-73, Arginine, Octenidine HCl, Camphor, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Limonene, Linalyl Acetate, Linalool, Mentha Piperita (Peppermint) Oil, Menthol, Terpineol, Vanillin, Lavandin Abrialis Oil, Illicium Verum Oil, Dipropylene Glycol, Pentadecalactone, Geraniol, Hexyl Acetate, Ethyl Amyl Ketone, Salvia Officnialis (Sage) Oil, 3-Hexenol

OTC - QUESTIONS SECTION

Questions?

1-877-NoFlake (1-877-663-5253)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

v2v2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73528-110-01Balancing280 mL in 1 BOTTLE, DISPENSINGSHAMPOO2801
73528-110-02Balancing85 mL in 1 BOTTLE, DISPENSINGSHAMPOO851
73528-110-03Balancing9 mL in 1 PACKETSHAMPOO91
73528-110-04Balancing250 mL in 1 BOTTLE, DISPENSINGSHAMPOO2501
73528-110-05Balancing415 mL in 1 BOTTLE, DISPENSINGSHAMPOO4151

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 59 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73528-11073528-110-01, 73528-110-02, 73528-110-03, 73528-110-04, 73528-110-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 58 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BalancingPYRITHIONE ZINCZero Flakes Given, Inc.4f9a51ba-aea6-081f-e063-6394a90a41222026-04-16WarningsExact identifier
ndc (package): 73528-110-03
ndc (package): 73528-110-01
ndc (package): 73528-110-04
ndc (package): 73528-110-02
ndc (package): 73528-110-05
ndc (product): 73528-110
ndc11 (package): 73528011005
ndc11 (package): 73528011004
ndc11 (package): 73528011001
ndc11 (package): 73528011002
ndc11 (package): 73528011003
spl id: 4f9a51ba-aea7-081f-e063-6394a90a4122
spl set id: 4f9a51ba-aea6-081f-e063-6394a90a4122

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.