FDA.reportPublic FDA data

AffirmCare Scalp Therapy

Manufacturer
Avlon Industries, Inc. | Avlon Industries Inc
Effective date
2024-02-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:10:42

Label at a glance#

ProductAffirmCare Scalp Therapy Hydrating Anti-Dandruff
Active ingredientPYRITHIONE ZINC
Label structure12 sections

Indications and uses

For the relief of scalp flaking, itching and irritation associated with dandruff and seborrheic dermatitis.

Dosage and administration

For best results, use at least twice a week, or as directed by a doctor. Shake well before use. Apply by massaging onto wet hair and scalp. Rinse and repeat. Follow with Scalp Therapy Hydrating Anti-Dandruff Conditioner.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione 1%

Purpose

OTC - PURPOSE SECTION

Anti-Dandruff, Anti-Seborrheic Dermatitis

Uses

INDICATIONS & USAGE SECTION

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 a condition that covers a large area of the body.

When Using This Product

OTC - WHEN USING SECTION

  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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, use at least twice a week, or as directed by a doctor.
  • Shake well before use.
  • Apply by massaging onto wet hair and scalp.
  • Rinse and repeat. Follow with Scalp Therapy Hydrating Anti-Dandruff Conditioner.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium
Laureth Sulfosuccinate, Betaine, Cocamidopropyl Betaine,
Cocamide MIPA, Sodium Cocoyl Isethionate, Cetyl Alcohol,
Melia Azadirachta Seed Oil, Origanum Vulgare Leaf Extract,
Linum Usitatissimum (Linseed) Seed Extract, Camellia
Sinensis Leaf Extract, Menthol, Keratin, Hydrolyzed Keratin,
Glycol Stearate, Glycerin, Piroctone Olamine, Phenoxyethanol,
Caprylyl Glycol, Caprylic Acid, Fragrance/Parfum,
Tetrasodium EDTA, Ceteareth-60 Myristyl Glycol,
Quaternium-80, Polyquaternium-10, Propanediol, Benzyl
Benzoate, Limonene, Hexyl Cinnamal.

OTC - QUESTIONS SECTION

Questions or comments? 1-800-332-8566

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AffirmCare Scalp Therapy

Hydrating Anti-Dandruff Shampoo (8 oz & 32 oz)

Product NDC# 63766-300

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63766-300-012024-02-29C16284748780-11030e365-5642-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Hydrating Anti-Dandruff Shampoo
63766-300-022024-02-29C16284748780-11030e365-5642-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Hydrating Anti-Dandruff Shampoo
63766-300-722024-02-29C16284748780-11030e365-5642-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Hydrating Anti-Dandruff Shampoo
63766-300-012024-01-30C16284748780-11030e365-5642-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Hydrating Anti-Dandruff Shampoo
63766-300-022024-01-30C16284748780-11030e365-5642-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Hydrating Anti-Dandruff Shampoo
63766-300-722024-01-30C16284748780-11030e365-5642-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Hydrating Anti-Dandruff Shampoo

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
63766-30063766-300-01, 63766-300-02, 63766-300-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIMONENE, (+)-GFD7C86Q1WIACT
BENZYL BENZOATEN863NB338GIACT
WATER059QF0KO0RIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
LINSEED OIL84XB4DV00WIACT
GLYCOL STEARATE0324G66D0EIACT
POLYQUATERNIUM-10 (125 MPA.S AT 2%)L45WU8S981IACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPANEDIOL5965N8W85TIACT
OREGANO0E5AT8T16UIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BETAINE3SCV180C9WIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MENTHOLL7T10EIP3AIACT
CETEARETH-60 MYRISTYL GLYCOL4O832ZOY6WIACT
EDETATE SODIUMMP1J8420LUIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
CAPRYLIC ACIDOBL58JN025IACT
HYDROLYZED SHEEP WOOL KERATIN (2000 MW)NZR037QF7ZIACT
AMINO ACIDS, HAIR KERATING46579QK1MIACT
2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID71X53V3RZ1IACT

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
2413b11e-ab39-3e77-e063-6294a90a92db75afe7e4-0895-58ea-e053-2a91aa0a91502024-10-09WarningsExact identifier
spl set id: 75afe7e4-0895-58ea-e053-2a91aa0a9150

Reported adverse events (FAERS/openFDA)#

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