MEDICEUTICALS X-DERMA DRY SCALP AND HAIR TREATMENT- salicylic acid shampoo 
Mediceutical Laboratories, Ltd.
Reference Label Set Id: c081c87b-9eb7-443b-82df-8d4dd2b51e73

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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Mediceutical Laboratories X-Derma Dry Scalp and Hair Treatment - Drug Facts

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 Label

MEDICEUTICALS X-DERMA  DRY SCALP AND HAIR TREATMENT
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-507
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59279-507-06180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:59279-507-12360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:59279-507-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/27/2012
Labeler - Mediceutical Laboratories, Ltd. (136770067)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Laboratories, LLC016754201manufacture(59279-507)

Revised: 12/2015
Document Id: 28021efc-b567-404f-e054-00144ff88e88
Set id: ad02bbdf-2680-4d03-bcf1-1ba74928373e
Version: 10
Effective Time: 20151228
 
Mediceutical Laboratories, Ltd.