FDA.reportPublic FDA data

J1003005 Jason Dandruff Relief

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:16:24

Label at a glance#

ProductJ1003005 Jason Dandruff Relief
Active ingredientSULFUR, SALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sulfur 2.4%

Salicylic Acid 2.2%

OTC - PURPOSE SECTION

Sulfur Controls Dandruff

Salicylic Acid Controls Seborrheic Dermatitis

INDICATIONS & USAGE SECTION

  • Controls recurrence of flaking, scaling and itching associated with dandruff
  • Helps prevent seborrheic dermatitis

WARNINGS SECTION

For external use only . Avoid contact with eyes.Rinse eyes throughly with water in case contact occurs.Discontinue use and consult your physician if irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

For best results, use at least three times each week. Wet hair and lather,massage into scalp. Rinse and repeat if desired.

INACTIVE INGREDIENT SECTION

Water (Aqua), Potassium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Cetyl Alcohol, Disodium Cocoamphodiacetate, Cocamidopropyl Betaine, Stearic Acid, Glycerin, Glyceryl Stearate SE, Sodium Laurylglucosides Hydroxypropylsulfonate, Olea Europaea (Olive) Fruit Oil (1), Rosmarinus Officinalis (Rosemary) Leaf Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Chenopodium Quinoa Seed (1), Camphor, Capryloyl Glycine, Disodium Cocoyl Glutamate, Maltodextrin, Menthol, Methyl Salicylate, Potassium Hydroxide, Sodium Chloride, Sodium PCA, Triethyl Citrate, Undecylenoyl Glycine, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Linalool

(1) Certified Organic Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1995471salicylic acid 2.2 % / sulfur 2.4 % Medicated ShampooPSN9
1995471salicylic acid 22 MG/ML / sulfur 24 MG/ML Medicated ShampooSCD9
1995471salicylic acid 2.2 % / sulfur 2.4 % Medicated ShampooSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-0030-82024-07-31C16284748780-1ba0f9c33-5153-a910-e053-dadaa90a0b85J10030 Jason Dandruff Shampoo Formula PF161761-02
61995-0030-82024-07-30C16284748780-1ba0f9c33-5153-a910-e053-dadaa90a0b85J10030 Jason Dandruff Shampoo Formula PF161761-02
61995-0030-82023-12-15C16284748780-1ba0f9c33-5153-a910-e053-dadaa90a0b85J10030 Jason Dandruff Shampoo Formula PF161761-02
61995-0030-82023-01-30C16284748780-1ba0f9c33-5153-a910-e053-dadaa90a0b85J10030 Jason Dandruff Shampoo Formula PF161761-02
61995-0030-82021-02-28C16284748780-1ba0f9c33-5153-a910-e053-dadaa90a0b85J10030 Jason Dandruff Shampoo Formula PF161761-02
61995-0030-82021-01-29C16284748780-1ba0f9c33-5153-a910-e053-dadaa90a0b85J10030 Jason Dandruff Shampoo Formula PF161761-02

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-0030-8J1003005 Jason Dandruff Relief355 g in 1 BOTTLESHAMPOO3559

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-0030J1003005 JASON DANDRUFF RELIEF (SULFUR, SALICYLIC ACID) SHAMPOO [THE HAIN CELESTIAL GROUP, INC.]9Current NDC, Legacy NDC, 1 package rows20240802_625e8306-78c4-3317-e053-2991aa0afe81.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-003061995-0030-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATEZ6GFR7R72YIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CHENOPODIUM QUINOA SEEDOO4K72NZ2XIACT
WATER059QF0KO0RIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
MALTODEXTRIN7CVR7L4A2DIACT
OLIVE OIL6UYK2W1W1EIACT
ROSEMARY OIL8LGU7VM393IACT
JOJOBA OIL724GKU717MIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
MENTHOLL7T10EIP3AIACT
METHYL SALICYLATELAV5U5022YIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
XANTHAN GUMTTV12P4NEEIACT
BENZYL ALCOHOLLKG8494WBHIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
UNDECYLENOYL GLYCINE4D20464K2JIACT
LINALOOL, (+/-)-D81QY6I88EIACT
SULFUR70FD1KFU70ACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
ALCOHOL3K9958V90MIACT
POTASSIUM COCOYL GLUTAMATEIR5T90R7LZIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SODIUM CHLORIDE451W47IQ8XIACT
DISODIUM COCOYL GLUTAMATEMBK0CP8F5AIACT

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
J1003005 Jason Dandruff ReliefSULFUR, SALICYLIC ACIDThe Hain Celestial Group, Inc.625e8306-78c4-3317-e053-2991aa0afe812024-07-31WarningsExact identifier
ndc (package): 61995-0030-8
ndc (product): 61995-0030
ndc11 (package): 61995003008
spl id: 1e9114c5-11a2-a1c5-e063-6294a90a7243
spl set id: 625e8306-78c4-3317-e053-2991aa0afe81

Reported adverse events (FAERS/openFDA)#

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