X-FOLATE  PLUS- coal tar 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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Mediceutical Laboratories - X-FOLATE PLUS (59279-516)

Active Ingredient

5% coal tar soluble extract

Purpose

anti-dandruff, anti-psoriasis, anti-seborrheic dermatitis

Uses

Helps control and prevent flaking & itching associated with dandruff and seborrheic dermatitis.

Warnings

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

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a poision control center right away. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

Directions

For best results use daily or until condition is under control or as directed by a physician. For maximum control use every time you shampoo.

  1. Apply shampoo to wet hair, massage into hair and scalp, leave on for 2-3 minutes.
  2. Thoroughly rinse and repeat if desired.
  3. Apply Therapeutic scalp and hair treatment rinse for 2-3 minutes, thoroughly rinse.


Consult your salon professional for additional Mediceuticals scalp and hair treatments specifically tailored for your condition.

Inactive Ingredients

Benzophenone-4, Caprylyl Glycol, Cocamidopropyl Betaine, Dicetyldimonium Chloride, Ethylhexyl Methoxycinnamate, Fragrance (Parfum), Hexylene Glycol, Magnesium Chloride, Menthol, Octocrylene, Olea Europea (Olive) Fruit Oil, Panthenol, Phenoxyethanol, Polyquaternium-7, Polyquaternium-10, Polysorbate 80, Salicylic Acid, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua).

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X-FOLATE   PLUS
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-516
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SULISOBENZONE (UNII: 1W6L629B4K)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DICETYLDIMONIUM CHLORIDE (UNII: 6F4SX2007N)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
MENTHOL (UNII: L7T10EIP3A)  
OCTOCRYLENE (UNII: 5A68WGF6WM)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59279-516-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/11/2021
2NDC:59279-516-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H03/11/2021
Labeler - Mediceutical Laboratories, LTD (080520685)
Registrant - Mediceutical Laboratories, LTD (080520685)

Revised: 1/2022
Document Id: d580d658-6540-39fe-e053-2a95a90a8830
Set id: 1797d6d4-f5d8-4178-b7ec-d64d97c6255f
Version: 4
Effective Time: 20220113
 
Mediceutical Laboratories, LTD