KeraCare Dry and Itchy Scalp Anti-Dandruff

Manufacturer
Avlon Industries, Inc.
Effective date
2024-10-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:24:15

Label at a glance#

ProductKeraCare Dry and Itchy Scalp Anti-Dandruff
Active ingredientPYRITHIONE ZINC
Label structure12 sections

Dosage and administration

Apply to wet hair and gently lather with fingertips. Rinse and repeat. Leave on 5 minutes. Shampoo with KeraCare® Hydrating Detangling Shampoo for a final sudsing. For best results, follow with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-Dandruff, Anti-Seborrheic Dermatitis

INDICATIONS & USAGE SECTION

Use for the relief of scalp flaking, itching and irritation associated with

dandruff and seborrheic dermatitis.

Warnings

WARNINGS SECTION

■ For external use only

-----------------------------------------------------------------------------------------------------

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ seborrheic dermatitis that covers large areas of your body.

-----------------------------------------------------------------------------------------------------

OTC - WHEN USING SECTION

When using this product

■ Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

■ Use caution in exposing skin to sunlight after applying this product. It may

increase your tendency to sunburn for up to 24 hours after application.

-----------------------------------------------------------------------------------------------------

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ Condition worsens or does not improve with regular use.

-----------------------------------------------------------------------------------------------------

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

  • Apply to wet hair and gently lather with fingertips. Rinse and repeat. Leave on 5 minutes. Shampoo with KeraCare® Hydrating Detangling Shampoo for a final sudsing. For best results, follow with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium Laureth Sulfosuccinate,

Cocamidopropyl Betaine, Cocamide MIPA, Polysorbate 20, Sodium Cocoyl

Isethionate, Cetyl Alcohol, Glycerin, Menthol, Piroctone Olamine, Pyrus Malus

(Apple) Fruit Extract, Citrus Limon (Lemon) Peel Extract , Camellia Sinensis Leaf

Extract, Fragrance/Parfum, Quaternium-80, Propanediol, Polyquaternium-10,

Caprylyl Glycol, Phenoxyethanol, Tetrasodium EDTA, Citric Acid, Benzyl Salicylate,

Hexyl Cinnamal, Linalool, Blue 1 (CI 42090).

RECENT MAJOR CHANGES SECTION

Dosage and Administration Section

Section 9

10/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo

Product NDC

63766-002

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN8
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD8
209884zinc pyrithione 1 % Medicated ConditionerSY8
209884zinc pyrithione 1 % Medicated ShampooSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63766-002-01KeraCare Dry and Itchy Scalp Anti-Dandruff240 mL in 1 BOTTLESHAMPOO2408
63766-002-02KeraCare Dry and Itchy Scalp Anti-Dandruff950 mL in 1 BOTTLESHAMPOO9508
63766-002-03KeraCare Dry and Itchy Scalp Anti-Dandruff15 mL in 1 POUCHSHAMPOO158

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63766-002KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]8Current NDC, Legacy NDC, 3 package rows20241012_6e7524d7-b280-485a-815e-8af078e8acda.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ51
Pyrithione ZincACTIVE MOIETYR953O2RHZ51
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2I1
AMMONIUM LAURETH-5 SULFATEINACTIVE INGREDIENT43ZIH89I481
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0B1
ARCTIUM LAPPA WHOLEINACTIVE INGREDIENT73070DU1LA1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CENTAUREA CYANUS FLOWERINACTIVE INGREDIENTQZ239038YC1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OG1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
COCO DIISOPROPANOLAMIDEINACTIVE INGREDIENTS485AM948Q1
DISTEARYL PHTHALAMIC ACIDINACTIVE INGREDIENT5552GSZ9LI1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
GARLICINACTIVE INGREDIENTV1V998DC171
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0E1
HEDERA HELIX LEAFINACTIVE INGREDIENTZP9XFG71A71
LAMIUM ALBUM FLOWERINACTIVE INGREDIENT62IB9494JA1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
NASTURTIUM OFFICINALE FLOWERING TOPINACTIVE INGREDIENTW1N2U8I64G1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740Y1
POLYQUATERNIUM-28 (1100000 MW)INACTIVE INGREDIENT6M8B654MEQ1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
ROSEMARYINACTIVE INGREDIENTIJ67X351P91
ST. JOHN'S WORTINACTIVE INGREDIENTUFH8805FKA1
TILIA CORDATA FLOWERINACTIVE INGREDIENTCFN6G1F6YK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63766-00263766-002-01, 63766-002-02, 63766-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 112 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BSHAMPOO, SUSPENSION / TOPICAL30 %w/wExact identifier — unii+route
12 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii+route
32 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
16 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route
32 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
16 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BAEROSOL / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii+route
32 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BSHAMPOO, SUSPENSION / TOPICAL30 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
24 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii+route
32 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BEMULSION / TOPICAL39.75 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
24 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii+route
32 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii+route
32 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
GLYCOL STEARATEGLYCOL STEARATE0324G66D0ESHAMPOO, SUSPENSION / TOPICAL5 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii+route
32 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
24 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BAEROSOL / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
24 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii+route
24 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
24 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BEMULSION / TOPICAL39.75 %w/wExact identifier — unii+route
12 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii+route
32 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route
32 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BSHAMPOO, SUSPENSION / TOPICAL30 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
24 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii+route
32 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route
32 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
24 equally ranked IID candidates
GLYCOL STEARATEGLYCOL STEARATE0324G66D0ESHAMPOO, SUSPENSION / TOPICAL5 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii+route
32 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii+route
32 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii+route
32 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BAEROSOL / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route
32 equally ranked IID candidates
GLYCOL STEARATEGLYCOL STEARATE0324G66D0ECREAM / TOPICAL1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii+route
32 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route
32 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii+route
32 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCOL STEARATEGLYCOL STEARATE0324G66D0ECREAM / TOPICAL1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
24 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route
32 equally ranked IID candidates
GLYCOL STEARATEGLYCOL STEARATE0324G66D0ESHAMPOO, SUSPENSION / TOPICAL5 %w/wExact identifier — unii+route
8 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
16 equally ranked IID candidates

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
KeraCare Dry and Itchy Scalp Anti-DandruffPYRITHIONE ZINCAvlon Industries, Inc.6e7524d7-b280-485a-815e-8af078e8acda2024-10-09WarningsExact identifier
ndc (package): 63766-002-03
ndc (package): 63766-002-01
ndc (package): 63766-002-02
ndc (product): 63766-002
ndc11 (package): 63766000202
ndc11 (package): 63766000201
ndc11 (package): 63766000203
spl id: 2413c357-63f7-0f41-e063-6394a90a2b3c
spl set id: 6e7524d7-b280-485a-815e-8af078e8acda

Reported adverse events (FAERS/openFDA)#

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