MEDICEUTICALS X-DERMA DRY SCALP AND HAIR TREATMENT- salicylic acid shampoo

Mediceuticals X-Derma by

Drug Labeling and Warnings

Mediceuticals X-Derma by is a Otc medication manufactured, distributed, or labeled by Mediceutical Laboratories, Ltd., Dhaliwal Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic Acid 1.8%

Purpose

Anti-dandruff, anti-seborrheic dermatitis

Uses

Helps prevent recurrence of flaking and itching
associated with dandruff and seborrheic dermatitis.

Warnings

For external use only. If condition worsens or does not improve after regular use of this product as directed, discontinue and consult a physician. If condition covers a large area of the body, consult your physician before using this product.

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

Directions

1. Wet hair with warm water. Distribute shampoo evenly onto scalp
and hair creating a rich lather. Rinse.
2. Reapply for maximum results. Rinse. Apply Therapeutic™ Scalp and
Hair Treatment Rinse working onto scalp and through the hair.
3. Thoroughly rinse.
Consult your Salon professional for additional Mediceuticals® scalp
and hair treatments specifically tailored for your condition.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Apigenin, Biotin, Biotynoyl Tripeptide-1, Butylene
Glycol, Butylphenyl Methyl Propional, Chamomilla Recutita (Matricaria) Flower
Extract, Citric Acid, Citronellol, Cocamide DEA, Cocamidopropyl Betaine, Cucumis
Sativus (Cucumber) Extract, Dimethicone, Fragrance (Parfum), Glycerin, Glycol
Stearate, Helianthus Annuus (Sunflower) Seed Extract, Linalool, Methylchloroisothiazolinone,
Methylisothiazolinone, Oleanic Acid, Panthenol, PEG-40 Hydrogenated
Castor Oil, PEG-150 Distearate, PPG-26-Buteth-26, Simmondsia Chinensis
(Jojoba) Seed Oil, Sodium C14-16 Olefin Sulfonate, Water (Aqua)

Image of Label

MediceuticalXDermaLabel180mL.jpg

INGREDIENTS AND APPEARANCE

MEDICEUTICALS X-DERMA  DRY SCALP AND HAIR TREATMENT
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59279-507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
APIGENIN (UNII: 7V515PI7F6)
BIOTIN (UNII: 6SO6U10H04)
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
1-BUTENE (UNII: LY001N554L)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CUCUMBER SEED (UNII: BT3S9L53JK)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER SEED (UNII: R9N3379M4Z)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PANTHENOL (UNII: WV9CM0O67Z)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59279-507-06	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 59279-507-12	360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 59279-507-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/27/2012

Labeler - Mediceutical Laboratories, Ltd. (136770067)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Laboratories, LLC		016754201	manufacture(59279-507)