REVITEALIZE ANTI DANDRUFF - salicylic acid shampoo 
Camellix, LLC

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 Ingredients:

Salicylic Acid 1.8%

Purpose: 

Help Control of flaking and itching associated with dandruff and scalp psoriasis

Uses:

For relief of itching and scalp flaking associated with dandruff, seborrheic dermatitis and psoriasis.

Warnings:

Keep out of reach of small children. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

If swallowed, get medical help or contact a Poison Control Center immediately. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.




Directions
For best control of dandruff, use every time you shampoo. Wet hair, massage shampoo onto scalp, wait for at least 2 minutes, rinse, repeat if necessary.
For best results use at least twice a week or as directed by a doctor


Inactive Ingredients
Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Stach Hydroxypropyltrimonium Chloride, Glycerol Laurate, Green Tea Leaf Extract, SD Alcohol 40 (Alcohol Denatured), Aloe barbadensis Leaf Juice, Polysorbate 20, Glycerin, Panthenol, Retinyl Palmitate, Cholecalciferol, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Zea Mays (Corn) Oil, Tetrasodium EDTA, DMDM Hydantoin.





label
REVITEALIZE  ANTI DANDRUFF
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54866-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid18 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERYL LAURATE (UNII: Y98611C087)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ORANGE OIL (UNII: AKN3KSD11B)  
CORN OIL (UNII: 8470G57WFM)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54866-000-02118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/01/2011
Labeler - Camellix, LLC (968429386)
Registrant - RAANI CORPORATION (067084681)
Establishment
NameAddressID/FEIBusiness Operations
RAANI CORPORATION067084681manufacture

Revised: 12/2011
Document Id: e9899fa4-a6c6-464f-9441-3b29af9a9fa2
Set id: a27273f7-d84f-4390-947b-3b9b5e0bca6e
Version: 2
Effective Time: 20111216
 
Camellix, LLC