X FOLATE- zinc pyrithione 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 - MEDICEUTICALS X-FOLATE (59279-506)

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 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).

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

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)

Revised: 1/2022
Document Id: d580e439-2711-74b2-e053-2995a90a513c
Set id: b4000706-acbe-4d55-97f9-6f003fe6cf5a
Version: 4
Effective Time: 20220113
 
Mediceutical Laboratories, LTD