KeraCare Dry and Itchy Scalp Anti-Dandruff

Manufacturer
Avlon Industries, Inc.
Effective date
2024-10-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:24:14

Label at a glance#

ProductKeraCare Dry and Itchy Scalp Anti-Dandruff
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Dosage and administration

For best results, shampoo first with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Shampoo. Distribute KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner throughout hair and cover with a plastic cap. Leave on a few minutes and rinse thoroughly. Style as usual.

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

For best results, shampoo first with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing
Shampoo. Distribute KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner
throughout hair and cover with a plastic cap. Leave on a few minutes and rinse thoroughly. Style
as usual.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Cocos Nucifera (Coconut) Oil, Betaine, Aloe Barbadensis Leaf Juice, Cetearyl
Alcohol, Cetyl Alcohol, Glycerin, Stearamidopropyl Dimethylamine, Behentrimonium Chloride,
Linum Usitatissimum (Linseed) Seed Extract, Quaternium-80, Piroctone Olamine, Menthol,
Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6,
Fragrance/Parfum, Polyquaternium-10, Dipropylene Glycol, Propanediol, Caprylyl Glycol,
Phenoxyethanol, Citric Acid, Polyacrylamide, Benzyl Salicylate, Hexyl Cinnamal, Linalool.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner

Product NDC 63766-003

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN7
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD7
209884zinc pyrithione 1 % Medicated ConditionerSY7
209884zinc pyrithione 1 % Medicated ShampooSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63766-003-01KeraCare Dry and Itchy Scalp Anti-Dandruff240 mL in 1 TUBELOTION2407
63766-003-02KeraCare Dry and Itchy Scalp Anti-Dandruff950 mL in 1 BOTTLELOTION9507
63766-003-03KeraCare Dry and Itchy Scalp Anti-Dandruff15 mL in 1 POUCHLOTION157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63766-003KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION [AVLON INDUSTRIES, INC.]7Current NDC, Legacy NDC, 3 package rows20241012_5d501ba0-a6f9-4f0d-86d5-0e8d9302737f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ51
Pyrithione ZincACTIVE MOIETYR953O2RHZ51
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2I1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DICETYLDIMONIUM CHLORIDEINACTIVE INGREDIENT6F4SX2007N1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E1
MAGNESIUM CITRATEINACTIVE INGREDIENTRHO26O1T9V1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PADIMATE OINACTIVE INGREDIENTZ11006CMUZ1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EF1
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWV1
POLYQUATERNIUM-10 (125 MPA.S AT 2%)INACTIVE INGREDIENTL45WU8S9811
POLYQUATERNIUM-32 (30000 MPA.S AT 2%)INACTIVE INGREDIENT2KSE7HSH3S1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A21
STEARALKONIUM CHLORIDEINACTIVE INGREDIENT0OUO26BB881
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63766-00363766-003-01, 63766-003-02, 63766-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML · Source PDF

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 1 · 60 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARALKONIUM CHLORIDESTEARALKONIUM CHLORIDE0OUO26BB88LOTION / TOPICAL3.15 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
12 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
12 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
12 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
12 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
12 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
12 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 equally ranked IID candidates
PEG-40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
4 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARALKONIUM CHLORIDESTEARALKONIUM CHLORIDE0OUO26BB88LOTION / TOPICAL3.15 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARALKONIUM CHLORIDESTEARALKONIUM CHLORIDE0OUO26BB88LOTION / TOPICAL3.15 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
12 equally ranked IID candidates
STEARALKONIUM CHLORIDESTEARALKONIUM CHLORIDE0OUO26BB88LOTION / TOPICAL3.15 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEG-40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEG-40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
12 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
12 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEG-40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
12 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.5d501ba0-a6f9-4f0d-86d5-0e8d9302737f2024-10-09WarningsExact identifier
ndc (package): 63766-003-02
ndc (package): 63766-003-01
ndc (package): 63766-003-03
ndc (product): 63766-003
ndc11 (package): 63766000301
ndc11 (package): 63766000303
ndc11 (package): 63766000302
spl id: 2413c5d7-f318-5d86-e063-6294a90ac993
spl set id: 5d501ba0-a6f9-4f0d-86d5-0e8d9302737f

Reported adverse events (FAERS/openFDA)#

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