VITALE SENSITIVE SCALP 12 IN 1 INSTANT RELIEF ANTI DANDRUFF SPRAY- salicylic acid spray

Vitale Sensitive Scalp 12 in 1 Instant Relief Anti Dandruff Spray by

Drug Labeling and Warnings

Vitale Sensitive Scalp 12 in 1 Instant Relief Anti Dandruff Spray 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]

Drug Facts

Active Ingredient	Purpose
1.8% Salicylic Acid	Anti-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) 

AFAM CONCEPT, INC.
Chicago, IL 60629

LONDON NW 10 6JH, UK

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

Registered # 1,387,930

INGREDIENTS AND APPEARANCE

VITALE SENSITIVE SCALP 12 IN 1 INSTANT RELIEF ANTI DANDRUFF SPRAY  
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49681-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49681-002-05	237 mL in 1 BOTTLE, SPRAY

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 - JF Labs, Inc. (047821728)

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