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
4
Source
legacy-cache
Hydrated at
2026-08-01 21:10:43

Label at a glance#

ProductAffirmCare Scalp Therapy Anti-Dandruff Exfoliating Masque
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 after rinsing Scalp Therapy Hydrating Anti-Dandruff Shampoo by gently massaging into hair and scalp. Rinse well.

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 after rinsing Scalp Therapy Hydrating Anti-Dandruff Shampoo by gently massaging into hair and scalp. Rinse well.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Betaine, Cetearyl Alcohol, Cocos
Nucifera (Coconut) Oil, Cetyl Alcohol, Juglans Regia (Walnut) Shell Powder, Glycerin,
Behentrimonium Chloride, Stearamidopropyl Dimethylamine, Phytosterols,
Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Melia
Azadirachta Seed Oil, Origanum Vulgare Leaf Extract, Nigella Sativa Seed Oil, Linum
Usitatissimum (Linseed) Seed Extract, Camellia Sinensis Leaf Extract, Menthol,
Keratin, Hydrolyzed Keratin, Piroctone Olamine, Panthenol, Polyquaternium-37,
PPG-1 Trideceth-6, Phenoxyethanol, Caprylyl Glycol, Caprylic Acid, Fragrance/Parfum,
Citric Acid, Isostearyl Ethylimidazolinium Ethosulfate, Polyacrylamide, Propylene
Glycol Dicaprylate/Dicaprate, Dipropylene Glycol, Amyl Cinnamal, Benzyl Benzoate,
Limonene, Hexyl Cinnamal.

OTC - QUESTIONS SECTION

Questions or comments?1-800-332-8566

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AffirmCare Scalp Therapy
Anti-Dandruff Exfoliating Masque (8 oz & 32 oz)

Product NDC# 63766-302

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63766-302-012024-02-29C16284748780-11030e365-0ca1-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Anti-Dandruff Exfoliating Masque
63766-302-022024-02-29C16284748780-11030e365-0ca1-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Anti-Dandruff Exfoliating Masque
63766-302-012024-01-30C16284748780-11030e365-0ca1-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Anti-Dandruff Exfoliating Masque
63766-302-022024-01-30C16284748780-11030e365-0ca1-111a-e063-dadaa90a10e2AffirmCare Scalp Therapy - Anti-Dandruff Exfoliating Masque

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63766-30263766-302-01, 63766-302-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
COCONUT OILQ9L0O73W7LIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETYL ALCOHOL936JST6JCNIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BETAINE3SCV180C9WIACT
GLYCERINPDC6A3C0OXIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
POLYQUATERNIUM-37 (10000 MPA.S)41QWS48DFNIACT
LINSEED OIL84XB4DV00WIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
CAPRYLIC ACIDOBL58JN025IACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEO4446S9CRAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
MENTHOLL7T10EIP3AIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PPG-1 TRIDECETH-61K7417JX6QIACT
OREGANO0E5AT8T16UIACT
BENZYL BENZOATEN863NB338GIACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
AMINO ACIDS, HAIR KERATING46579QK1MIACT
HYDROLYZED SHEEP WOOL KERATIN (2000 MW)NZR037QF7ZIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
ISOSTEARYL ETHYLIMIDAZOLINIUM ETHOSULFATEMZE1E3A2ZSIACT
JUGLANS REGIA WHOLE87EJ76IO83IACT
PANTHENOLWV9CM0O67ZIACT
LIMONENE, (+)-GFD7C86Q1WIACT
.BETA.-SITOSTEROLS347WMO6M4IACT

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-ab38-3e77-e063-6294a90a92db75c55e45-16a6-5b97-e053-2a91aa0ae9682024-10-09WarningsExact identifier
spl set id: 75c55e45-16a6-5b97-e053-2a91aa0ae968

Reported adverse events (FAERS/openFDA)#

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