X FOLATE- 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 (59279-505)DELIST

Active Ingredient

5% coal tar extract 0.75

Purpose

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

Uses

Helps prevent and control itching and flaking associated with dandruff, psoriasis 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

For best results use at least twice a week or as directed by a physician.
For maximum control, use every time you shampoo.

Wet hair massage a liberal amount of X-Folate into the scalp and leave on for 1-2 minutes.
Thorough rinse and repeat if desired.

Apply Therapeutic Scalp and Hair Treatment Rinse for 1-2 minutes, thoroughly rinse. For persistent dandruff and psoriasis use TheraRx as a pre-shampoo treatment.
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, Polyquaterniuim-7, Polyquaternium-10, Polysorbate 80, Salicylic Acid, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua)

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X FOLATE 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-505
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SULISOBENZONE (UNII: 1W6L629B4K)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
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)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59279-505-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/199303/11/2021
2NDC:59279-505-12360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/199303/11/2021
3NDC:59279-505-06180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/199303/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/199303/11/2021
Labeler - Mediceutical Laboratories, LTD (080520685)
Establishment
NameAddressID/FEIBusiness Operations
United 1 International Laboratories807878116manufacture(59279-505)

Revised: 1/2022
 
Mediceutical Laboratories, LTD