Hair Sanity

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:06

Label at a glance#

ProductHair Sanity Hair Sanity Part I
Active ingredientHYDROCORTISONE ACETATE
Label structure7 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations and rashes.

Dosage and administration

Apply a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. Add additional water and cleanser for increased lather. Massage lather into scalp and rinse thoroughly with warm water. Use daily or minimum of 3 times per week.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone acetate 0.5%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-Itch)

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of itching associated with minor skin irritations and rashes.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with the eyes.

OTC - ASK DOCTOR SECTION

If conditions worsens or if symptoms persist, stop use of this product and consult a doctor.

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 a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. Add additional water and cleanser for increased lather. Massage lather into scalp and rinse thoroughly with warm water. Use daily or minimum of 3 times per week.

INACTIVE INGREDIENT SECTION

Water, Sodium Lauroyl Methyl Isethionate, Acrylates Copolymer, Decyl Glucoside, Sodium Lauroamphoacetate, Sodium Methyl Cocoyl Taurate, Sodium Cocoyl Isethionate, Butylene Glycol, Glycereth-26, Cocamidopropyl Betaine, Fragrance, Glycerin, Glycol Stearate, Phenoxyethanol, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Allantoin, BHT, Disodium EDTA, Ethylhexylglycerin, Caprylic/Capric Triglyceride, Methylpropanediol, 4-Terpineol, Isomalt, Rhododendron Ferrugineum Leaf Cell Culture Extract, Lecithin, Lactic Acid, Salicylic Acid, Sea Whip Extract, Salix Alba (Willow) Bark Extract

Hair Sanity Part I

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489373hydrocortisone acetate 0.5 % Medicated ShampooPSN2
1489373hydrocortisone acetate 5 MG/ML Medicated ShampooSCD2
1489373hydrocortisone acetate 0.5 % Medicated ShampooSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0246-42024-01-30C16284748780-11030e365-0fba-111a-e063-dadaa90a10e2Hair Sanity Part I

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0246-4Hair SanityHair Sanity Part I237 mL in 1 TUBELOTION/SHAMPOO2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0246HAIR SANITY HAIR SANITY PART I (HYDROCORTISONE ACETATE) LOTION/SHAMPOO [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200118_4d72d38f-aaa8-1f57-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-024658443-0246-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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
9c59afdf-48ac-4be1-e053-2a95a90a91894d72d38f-aaa8-1f57-e054-00144ff88e882020-01-17WarningsExact identifier
spl id: 9c59afdf-48ac-4be1-e053-2a95a90a9189
spl set id: 4d72d38f-aaa8-1f57-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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