Vitale Sensitive Scalp Daily Scalp Healer

Manufacturer: New Life Products, Inc.
Effective date: 2021-01-21
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:37:27

Label at a glance#

ProductVitale Sensitive Scalp Daily Scalp Healer

Active ingredientPYRITHIONE ZINC

Label structure8 sections

Dosage and administration

For best results apply to affected areas one to four times daily or as directed by a doctor. Spread a small amount in the palms of your hands and apply evenly to the scalp and entire head of hair. Style as desired.

Contacts and useful links#

PhoneLabel contact(800) 262-2326

PhoneLabel contact(773) 838-1336

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.25%

Purpose

OTC - PURPOSE SECTION

Anti-Dandruff

Use

INDICATIONS & USAGE SECTION

Controls the symptoms of dandruff

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have a condition that covers a large area of the body.

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

Stop use and ask adoctor if condition worsens or dowes 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 Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Propylene Glycol, Mineral Oil (Paraffinum Liquidum), Lanolin, Acetamide MEA, Cetyl Alcohol, Cetearyl Alcohol, Polysorbate 60, Beeswax, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Menthol, Camphor, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Juice, Dimethicone, Tocopherol Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Stearalkonium Chloride, Polyquaternium-11, Biotin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Equisetum Arvense Extract, Humulus Lupulus (Hops) Extract, Citrus Medica Limonum, (Lemon) Peel Extract, Sodium Borate, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance, (Parfum)

SPL UNCLASSIFIED SECTION

AFAM CONCEPT, INC.
Chicago, IL 60629

London NW 10 6JH
UK

(800) 262-2326
(773) 838-1336

Registered # 1,387,930

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
259549	zinc pyrithione 0.25 % Topical Cream	PSN	2
259549	zinc pyrithione 2.5 MG/ML Topical Cream	SCD	2
259549	zinc pyrithione 0.25 % Topical Cream	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49681-001-01	2023-01-30	C162847	48780-1	956f9ecf-c834-621f-e053-dbdaa90a74ad	9aeada50-2cb2-d113-126a-ddcf05f817b6
49681-001-01	2021-01-26	C162847	48780-1	956f9ecf-c834-621f-e053-dbdaa90a74ad	9aeada50-2cb2-d113-126a-ddcf05f817b6
49681-001-01	2019-10-21	C162847	48780-1	956f9ecf-c834-621f-e053-dbdaa90a74ad	9aeada50-2cb2-d113-126a-ddcf05f817b6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49681-001-01	Vitale Sensitive Scalp Daily Scalp Healer	114 g in 1 JAR	CREAM	114		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49681-001	VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [NEW LIFE PRODUCTS, INC.]	2	Legacy NDC, 1 package rows	20210128_9aeada50-2cb2-d113-126a-ddcf05f817b6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Pyrithione Zinc	ACTIVE INGREDIENT	R953O2RHZ5	1
Pyrithione Zinc	ACTIVE MOIETY	R953O2RHZ5	1
1,3-dimethylol-5,5-dimethyl-hydantoin	INACTIVE INGREDIENT	BYR0546TOW	1
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
Alpha-tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
Biotin	INACTIVE INGREDIENT	6SO6U10H04	1
Camphor	INACTIVE INGREDIENT	5TJD82A1ET	1
Cetostearyl Alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
Equisetum Arvense Extract	INACTIVE INGREDIENT	1L0VKZ185E	1
Eucalyptus Oil	INACTIVE INGREDIENT	2R04ONI662	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	1
Olive Oil	INACTIVE INGREDIENT	6UYK2W1W1E	1
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
Sodium Borate	INACTIVE INGREDIENT	91MBZ8H3QO	1
Stearalkonium Chloride	INACTIVE INGREDIENT	0OUO26BB88	1
Vitamin A Palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Wax, Yellow	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

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

Vitale Sensitive Scalp Daily Scalp Healer
Pyrithione Zinc
WATER
GLYCERIN
PROPYLENE GLYCOL
MINERAL OIL
LANOLIN
ACETIC MONOETHANOLAMIDE
CETYL ALCOHOL
CETOSTEARYL ALCOHOL
POLYSORBATE 60
YELLOW WAX
WHEAT GERM OIL
OLIVE OIL
JOJOBA OIL
MENTHOL, UNSPECIFIED FORM
CAMPHOR (SYNTHETIC)
EUCALYPTUS OIL
ALOE VERA LEAF
DIMETHICONE
.ALPHA.-TOCOPHEROL ACETATE
VITAMIN A PALMITATE
STEARALKONIUM CHLORIDE
POLYQUATERNIUM-11 (1000000 MW)
BIOTIN
ROSEMARY
EQUISETUM ARVENSE BRANCH
HOPS
LEMON PEEL
SODIUM BORATE
DMDM HYDANTOIN
METHYLPARABEN
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49681-001	49681-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PYRITHIONE ZINC	R953O2RHZ5	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
MINERAL OIL	T5L8T28FGP	IACT
LANOLIN	7EV65EAW6H	IACT
ACETIC MONOETHANOLAMIDE	A9O0818TWD	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
YELLOW WAX	2ZA36H0S2V	IACT
WHEAT GERM OIL	14C97E680P	IACT
OLIVE OIL	6UYK2W1W1E	IACT
JOJOBA OIL	724GKU717M	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
DIMETHICONE	92RU3N3Y1O	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
STEARALKONIUM CHLORIDE	0OUO26BB88	IACT
POLYQUATERNIUM-11 (1000000 MW)	0B44BS5IJS	IACT
BIOTIN	6SO6U10H04	IACT
ROSEMARY	IJ67X351P9	IACT
EQUISETUM ARVENSE BRANCH	1L0VKZ185E	IACT
HOPS	01G73H6H83	IACT
LEMON PEEL	72O054U628	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 427 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Wax, Yellow	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Cetostearyl Alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	OINTMENT / TOPICAL	2 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Borate	SODIUM BORATE	91MBZ8H3QO	SUSPENSION/ DROPS / OPHTHALMIC	0.03 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Borate	SODIUM BORATE	91MBZ8H3QO	EMULSION / OPHTHALMIC	0.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a09678e5-709e-4af9-a4e2-b4c2c00f2621			9aeada50-2cb2-d113-126a-ddcf05f817b6	2021-01-21	Warnings	Exact identifier spl id: a09678e5-709e-4af9-a4e2-b4c2c00f2621 spl set id: 9aeada50-2cb2-d113-126a-ddcf05f817b6

Reported adverse events (FAERS/openFDA)#

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