Label: X FOLATE- zinc pyrithione shampoo

  • 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

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  • ACTIVE INGREDIENT

    1% ZINC PYRITHIONE

  • 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
    and consult a physician. If condition covers large area of the body, consult your physician before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    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

    Water (Aqua), Sodium Olefin Sulfonate, Decyl Glucoside, Cocamide MEA, Cocamidopropyl Hydroxysultaine, Zinc Pyrithione, Phenoxyethanol, Sodium Chloride, Climbazole, Polyquaternium-10 Panthenol, Allantoin, Fragrance (Parfum).

  • PRINCIPAL DISPLAY PANEL

    01b LBL_X-Folate_Zinc P 1pct_1-L_front

    01b LBL_X-Folate_Zinc P 1pct_1-L_back

    01b LBL_X-Folate_Zinc P 1pct_250mL_front

    01b LBL_X-Folate_Zinc P 1pct_250mL_back

  • INGREDIENTS AND APPEARANCE
    X FOLATE 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CLIMBAZOLE (UNII: 9N42CW7I54)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59279-506-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2021
    2NDC:59279-506-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/29/2021
    Labeler - Mediceutical Laboratories, LTD (080520685)
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