VITALE SENSITIVE SCALP 12 IN 1 INSTANT RELIEF ANTI DANDRUFF SPRAY - salicylic acid spray 
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 IngredientPurpose
1.8% Salicylic AcidAnti-dandruff, anti seborrheic dermatitis, anti-psoriasis

USE

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis.

WARNINGS SECTION

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

Flammable.  Keep away from heat and open flame.

For external use only

Ask a physician before use it you have a condition that covers a large area of your body.

Avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

If condition worsens or does not improve, after regular use of this product as directed, consult a physician.

DOSAGE AND ADMINISTRATION SECTION

Directions:  Hold bottle 6 inches away from hair and spray evenly.  Massage into hair and scalp and style.  For curly hair and braids, use daily.  On relaxed hair use before drying.

Other Information:  Store away from direct sunlight.

INACTIVE INGREDIENT SECTION

Inactive ingedients:  Water(Aqua), SD Alcohol 40B, Propylene Glycol, Cyclo-pentasiloxane, Isopropyl Palmitate, Phenyl Trimethicone, Sodium Citrate, Sodium Hydroxide, PPG-5 Ceteth-20, Olea Europaea (Olive) Oil, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Camphor, Menthol, Cetrimonium Chloride, Sulfur, Polysorbate-20, Methylparaben, Propylparaben, Tocopherol Acetate (Vitamin E), Retinyl Palmitate (Vitmin A), Rosmarinus Officinalis (Rosemary) Leaf Extract, Equisetum Arvense Extract, Pinus Sylvestris Leaf Extract, Humulus Lupulus (Hops) Extract, Citrus Limonum (Lemon) Peel Extract, Fragrance (Parfum) 

 

Vitale 12 in 1 Spray Label

AFAM CONCEPT, INC.
Chicago, IL 60629

LONDON NW 10 6JH, UK

www.vitaleproducts.com 
(773)838-1336, (800) 262-2326

Registered # 1,387,930

VITALE SENSITIVE SCALP 12 IN 1 INSTANT RELIEF ANTI DANDRUFF SPRAY  
salicylic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Olive Oil (UNII: 6UYK2W1W1E)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Peppermint Oil (UNII: AV092KU4JH)  
Camphor (UNII: 5TJD82A1ET)  
Menthol (UNII: L7T10EIP3A)  
Cetrimonium Chloride (UNII: UC9PE95IBP)  
Sulfur (UNII: 70FD1KFU70)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Alpha-tocopherol Acetate (UNII: 9E8X80D2L0)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Equisetum Arvense Extract (UNII: 1L0VKZ185E)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49681-002-05237 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35811/01/2009
Labeler - JF Labs, Inc. (047821728)
Registrant - JF Labs, Inc. (047821728)
Establishment
NameAddressID/FEIBusiness Operations
Afam Concept, Inc.103330098MANUFACTURE

Revised: 9/2009
Document Id: 4666b310-b806-f603-4c2d-2e94761169bb
Set id: 2ea0ccef-2f41-813b-6fe3-d695fc8775eb
Version: 1
Effective Time: 20090916
 
JF Labs, Inc.