REVITEALIZE ANTI DANDRUFF- salicylic acid shampoo

REVITEALIZE by

Drug Labeling and Warnings

REVITEALIZE by is a Otc medication manufactured, distributed, or labeled by Camellix, LLC, RAANI CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Salicylic Acid 1.8%

PURPOSE

Purpose: 

Help Control of flaking and itching associated with dandruff

INDICATIONS & USAGE

Uses:

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

WARNINGS

Warnings:

• For external use only.

KEEP OUT OF REACH OF CHILDREN

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

ASK DOCTOR

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVITEALIZE  ANTI DANDRUFF
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54866-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	18 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54866-000-01	250 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/01/2011

Labeler - Camellix, LLC (968429386)

Registrant - RAANI CORPORATION (067084681)

Establishment
Name	Address	ID/FEI	Business Operations
RAANI CORPORATION		067084681	manufacture