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Name:Vitale Sensitive Scalp Daily Scalp Healer
Manufacturer:Jf Labs, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


VITALE SENSITIVE SCALP DAILY SCALP HEALER - pyrithione zinc cream 
JF Labs, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Vitale Daily Scalp Healer Box Label

Jar label

Vitale Daily Scalp Healer Jar Label

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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc 250 mg  in 100 g
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Propylene Glycol  
Water  
1,3-dimethylol-5,5-dimethyl-hydantoin  
Cetostearyl Alcohol  
Vitamin A Palmitate  
Alpha-tocopherol Acetate  
Wax, Yellow  
Propylparaben  
Methylparaben  
Dimethicone  
Eucalyptus Oil  
Sodium Borate  
Menthol  
Equisetum Arvense Extract  
Stearalkonium Chloride  
Camphor  
Aloe Vera Leaf  
Biotin  
Olive Oil  
Polysorbate 60  
Cetyl Alcohol  
Mineral Oil  
Product Characteristics
Color WHITE (Off white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49681-001-01 114 g in 1 JAR None

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 Operations
Afam Concept, Inc. 103330098 MANUFACTURE

Revised: 09/2009 JF Labs, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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