MEDICEUTICALS X-DERMA DRY SCALP AND HAIR TREATMENT - salicylic acid shampoo 
Mediceutical Laboratories, Ltd.

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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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.jpgLabel


MEDICEUTICALS X-DERMA  DRY SCALP AND HAIR TREATMENT
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-507
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid1.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf 
Apigenin 
Biotin 
Biotinoyl Tripeptide-1 
1-Butene 
Butylphenyl Methylpropional 
Chamomile 
Citric Acid Monohydrate 
.Beta.-Citronellol, (R)- 
Coco Diethanolamide 
Cocamidopropyl Betaine 
Cucumber Seed 
Dimethicone 
Glycerin 
Sunflower Seed 
Linalool, (+/-)- 
Methylchloroisothiazolinone 
Methylisothiazolinone 
Panthenol 
Polyoxyl 40 Hydrogenated Castor Oil 
PEG-150 Distearate 
Simmondsia Chinensis Seed Wax 
Sodium C14-16 Olefin Sulfonate 
Water 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:59279-507-06180 mL in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/16/2012

Labeler - Mediceutical Laboratories, Ltd. (136770067)
Establishment
NameAddressID/FEIOperations
Mediceutical Laboratories, Ltd.136770067manufacture

Revised: 01/2012 Mediceutical Laboratories, Ltd.