FDA.reportPublic FDA data

Ouai Anti-Dandruff

Manufacturer
United Beauty Brands, LLC
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:33

Label at a glance#

ProductOuai Anti-Dandruff
Active ingredientSalicylic Acid
Label structure10 sections

Dosage and administration

Apply to wet hair and massage into scalp. Leave on for 5 minutes and rinse thoroughly. For best results use at least twice a week or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Anti-Dandruff

Use

INDICATIONS & USAGE SECTION

Reduces scalp flaking, itching, and irritation associated with dandruff

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to wet hair and massage into scalp.
  • Leave on for 5 minutes and rinse thoroughly.
  • For best results use at least twice a week or as directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Glycerin, Sodium Lauroyl Methyl Isethionate, Polysorbate 80, Acrylates Copolymer, Propanediol Caprylate, Potassium Hydroxide, Sodium Benzoate, Sodium Methyl Oleoyl Taurate, Sodium Cocoyl Isethionate, Cocamide MIPA, Cassia Hydroxypropyltrimonium Chloride, Polyquaternium-113, Chlorphenesin, Tetrasodium EDTA, Silicone Quaternium-22, Dipropylene Glycol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Polyglyceryl-3 Caprate, PEG-45M, Citric Acid, Fragrance.

Questions or comments

OTC - QUESTIONS SECTION

team@theouai.com

SPL UNCLASSIFIED SECTION

DIST. BY OUAI BEVERLY HILLS,
CA 90210 USA

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OUAI

ANTI-DANDRUFF SHAMPOO

2% SALICYLIC ACID

10 fl oz / 300 ml

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83058-0140-12026-01-29C16284748780-149896155-bcf2-586f-e063-e6dba90add90Ouai Anti-Dandruff Shampoo
83058-0140-42026-01-29C16284748780-149896155-bcf2-586f-e063-e6dba90add90Ouai Anti-Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83058-0140-1Ouai Anti-Dandruff300 mL in 1 BOTTLE, PLASTICSHAMPOO3002
83058-0140-4Ouai Anti-Dandruff30 mL in 1 TUBESHAMPOO302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83058-0140OUAI ANTI-DANDRUFF (SALICYLIC ACID) SHAMPOO [UNITED BEAUTY BRANDS, LLC]2Legacy NDC, 2 package rows20240119_10d146c2-7108-43c0-9f10-726d14cc9433.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83058-014083058-0140-1, 83058-0140-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
water059QF0KO0RIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Sodium C14-16 Olefin SulfonateO9W3D3YF5UIACT
GlycerinPDC6A3C0OXIACT
Sodium Lauroyl Methyl IsethionateII6VCD3S6RIACT
Polysorbate 806OZP39ZG8HIACT
Acrylates Crosspolymer-4GEV2EL4D9GIACT
Propanediol Caprylate7641PCH336IACT
Potassium HydroxideWZH3C48M4TIACT
Sodium BenzoateOJ245FE5EUIACT
Sodium Methyl Oleoyl Taurate8PZ076134HIACT
Sodium Cocoyl Isethionate518XTE8493IACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
ChlorphenesinI670DAL4SZIACT
EDETATE SODIUMMP1J8420LUIACT
Dipropylene GlycolE107L85C40IACT
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP08H094218DIACT
Polyglyceryl-3 CaprateVZQ347QQ3HIACT
POLYETHYLENE OXIDE 20000005K3991GVWIIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
d0d79d4d-5240-4624-ac80-cc04447476bb10d146c2-7108-43c0-9f10-726d14cc94332024-01-11WarningsExact identifier
spl id: d0d79d4d-5240-4624-ac80-cc04447476bb
spl set id: 10d146c2-7108-43c0-9f10-726d14cc9433

Reported adverse events (FAERS/openFDA)#

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