Label: VITALE SENSITIVE SCALP 12 IN 1 INSTANT RELIEF ANTI DANDRUFF SPRAY- salicylic acid spray
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Contains inactivated NDC Code(s)
NDC Code(s): 49681-002-05 - Packager: JF Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 16, 2009
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- USE
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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
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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)
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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 sprayProduct 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