OTC Medication Information: X FOLATE

X FOLATE- pyrithione zinc 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.

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).

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X FOLATE
zinc pyrithione shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59279-506
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM C14-16 OLEFIN SULFONATE
DECYL GLUCOSIDE
COCO MONOETHANOLAMIDE
COCAMIDOPROPYL HYDROXYSULTAINE
PHENOXYETHANOL
SODIUM CHLORIDE
CLIMBAZOLE
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)
PANTHENOL
ALLANTOIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59279-506-33 1000 mL in 1 BOTTLE None
2 NDC:59279-506-08 250 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 04/29/2021
Labeler — Mediceutical Laboratories, LTD (080520685)

Revised: 01/2022 Mediceutical Laboratories, LTD

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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