EczaCalm

Manufacturer
I Shay Cosmetics Inc
Effective date
2022-10-10
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:52:02

Label at a glance#

ProductBeauty and Health Research, Inc.
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Dosage and administration

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 2 times a week, or as directed by a doctor. For maximum dandruff control, use every time you shampoo.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

zinc pyrithione 2% anti-dandruff

Use

OTC - PURPOSE SECTION

For relief of symptoms of scalp itch, irritation, flaking, and redness associated with dandruff

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNING: Keep out of reach of children. If swallowed call a poison control center or get medical attention immediately.

Use

INDICATIONS & USAGE SECTION

For relief of symptoms of scalp itch, flaking, and redness associated with dandruff.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl betaine, Glycerin, Cocamide MEA, Polyquaternium-7, Nettle Leaf Extract, Hops Flower Extract, Grapefruit Peel Extract, Sodium Chloride, Sodium Trideceth Sulfate, Phenoxyethanol, Methyl Paraben, Saccharomyces/Zinc/Ferment, Saccharomyces/Copper Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Iron Ferment, Saccharomyces/Silicon Ferment, Lavender Oil, Biotin/Folic Acid/Cyanocobalamin/Niacinamide/Pantothenic Acid/Pyridoxine/Riboflavin/Thiamine/Yeast Peptides, Yeast Extract, Citric Acid, Sodium Benzoate, Rosemary Oil, Salicylic Acid, Lecithin, Tea Tree Oil, Peppermint Oil, Cedarwood Oil, Blue #1

Warnings

WARNINGS SECTION

Warnings: For external use only. Avoid contact with eyes. If contact occurs with eyes, rinse thoroughly wash with water.

If conditions worsen or does not improive with regular use of this product, consult a doctor.

Keep out of children's reach. If swallowed call a poison control center or get medical attention immediately.

Do not use on children under the age of 2, unless directed by a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

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 2 times a week, or as directed by a doctor.

For maximum dandruff control, use every time you shampoo.

Label pic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65112-26265112-262-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
eab2e339-c9e8-3048-e053-2995a90ae14992dcd064-5d9d-29b6-e053-2a95a90a1bf12022-10-10WarningsExact identifier
spl id: eab2e339-c9e8-3048-e053-2995a90ae149
spl set id: 92dcd064-5d9d-29b6-e053-2a95a90a1bf1

Reported adverse events (FAERS/openFDA)#

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