You are here: Home > Over-the-counter (OTC) Drugs > V > Vitale Sensitive Scalp 12 In 1 Instant Relief Anti Dandruff Spray (Jf Labs, Inc.)

Name:Vitale Sensitive Scalp 12 In 1 Instant Relief Anti Dandruff Spray
Manufacturer:Jf Labs, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


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 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) 

 

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49681-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (Salicylic Acid) Salicylic Acid 15 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Alcohol  
Propylene Glycol  
Isopropyl Palmitate  
Sodium Citrate  
Sodium Hydroxide  
Olive Oil  
Aloe Vera Leaf  
Peppermint Oil  
Camphor  
Menthol  
Cetrimonium Chloride  
Sulfur  
Polysorbate 20  
Methylparaben  
Propylparaben  
Alpha-tocopherol Acetate  
Vitamin A Palmitate  
Equisetum Arvense Extract  
Cyclomethicone 5  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49681-002-05 237 mL in 1 BOTTLE, SPRAY 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 - JF Labs, Inc. (047821728)
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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