Label: X-FOLATE PLUS- coal tar shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 59279-516-08, 59279-516-33 - Packager: Mediceutical Laboratories, LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 13, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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.
- Apply shampoo to wet hair, massage into hair and scalp, leave on for 2-3 minutes.
- Thoroughly rinse and repeat if desired.
- 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).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
X-FOLATE PLUS
coal tar shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59279-516 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:59279-516-33 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/11/2021 2 NDC:59279-516-08 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 03/11/2021 Labeler - Mediceutical Laboratories, LTD (080520685) Registrant - Mediceutical Laboratories, LTD (080520685)