VITALE SENSITIVE SCALP DAILY SCALP HEALER- pyrithione zinc cream

Vitale Sensitive Scalp Daily Scalp Healer by

Drug Labeling and Warnings

Vitale Sensitive Scalp Daily Scalp Healer by is a Otc medication manufactured, distributed, or labeled by JF Labs, Inc., Afam Concept, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient	Purpose
Pyrithione Zinc 0.25%	Anti-Dandruff

Use Controls the symptoms of dandruff

WARNINGS

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.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions:

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.

Inactive ingredients

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)

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AFAM CONCEPT, INC.
Chicago, IL 60629

London NW 10 6JH
UK

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

Registered # 1,387,930

Box label

Jar label

INGREDIENTS AND APPEARANCE

VITALE SENSITIVE SCALP DAILY SCALP HEALER 
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49681-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	250 mg  in 100 g

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

Product Characteristics
Color	WHITE (Off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49681-001-01	114 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358	11/01/2009

Labeler - JF Labs, Inc. (047821728)

Registrant - Afam Concept, Inc. (103330098)

Establishment
Name	Address	ID/FEI	Business Operations
Afam Concept, Inc.		103330098	MANUFACTURE