Vitale Sensitive Scalp Daily Scalp Healer

Dosage form: cream
Ingredients: Pyrithione Zinc 250mg in 100g
Labeler: JF Labs, Inc.
NDC Code: 49681-001

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 IngredientPurpose
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
VITALE SENSITIVE SCALP DAILY SCALP HEALER 
pyrithione zinc cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc250 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (Off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49681-001-01114 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35811/01/2009
Labeler - JF Labs, Inc. (047821728)
Registrant - Afam Concept, Inc. (103330098)
Establishment
NameAddressID/FEIOperations
Afam Concept, Inc.103330098MANUFACTURE

Revised: 09/2009
 
JF Labs, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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