Mediceuticals X-Derma Dry Scalp and Hair Treatment

Dosage form: shampoo
Ingredients: Salicylic Acid 1.8g in 100mL
Labeler: Mediceutical Laboratories, Ltd.
NDC Code: 59279-507

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.

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

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 g  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 
Packaging
#Item CodePackage Description
1NDC:59279-507-06180 mL in 1 BOTTLE, PLASTIC
2NDC:59279-507-12360 mL in 1 BOTTLE, PLASTIC
3NDC:59279-507-331000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/27/2012
Labeler - Mediceutical Laboratories, Ltd. (136770067)
Establishment
NameAddressID/FEIOperations
Dhaliwal Labs016754201manufacture(59279-507)

Revised: 11/2012
 
Mediceutical Laboratories, Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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