Label: HAIRITAGE WASH IT AWAY ANTI-DANDRUFF FOR OILY, FLAKY SCALP- selenium sulfide liquid

  • 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 April 10, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active Ingredients

    Selenium Sulfide 1.0%

  • Purpose

    Anti-Dandruff/Anti-Seborrheic Dermatitis Shampoo

  • Uses

    • Helps eliminate scalp itching, irritation, redness, flaking associated with dandruff and/or seborrheic dermatitis.
  • Warnings

    • For external use only.
    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • Stop use and consult a doctor if condition worsens or does not improve after regular use of this product as directed.
    • If condition covers a large area of the body, consult your doctor before using this product.

    • Keep out of reach of children.
      If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Shake well before each use.
    • Apply to wet hair and massage, from scalp to ends. Rinse thoroughly and follow with Hairitage Balancing Conditioner. Substitute Hairitage Anti-Dandruff Shampoo with your regular shampoo every other wash, or when you notice oily and/or flaky scalp.
    • For best results use at least twice a week or as directed by a doctor.
  • Inactive Ingredients

    WATER (AQUA/EAU), AMMONIUM LAURETH SULFATE, COCAMIDE MEA, COCAMIDOPROPYL BETAINE, PHENOXYETHANOL, MAGNESIUM ALUMINUM SILICATE, ACRYLATES COPOLYMER, SODIUM CHLORIDE, FRAGRANCE (PARFUM), CITRIC ACID, CHLORPHENESIN, GLYCERIN, SODIUM HYDROXIDE, MENTHOL, CAPRYLYL GLYCOL, AMMONIUM SULFATE, SODIUM METABISULFITE, TETRASODIUM EDTA, METHYLISOTHIAZOLINONE, METHYLCHLOROISOTHIAZOLINONE, AMMONIUM CHLORIDE, TRISODIUM NTA, HYDROXYPROPYL METHYLCELLULOSE, GLYOXAL, FORMIC ACID, C10-16 ALCOHOLS, BENZYL SALICYLATE, LINALOOL, HEXYL CINNAMAL, CITRONELLOL, EUGENOL, LIMONENE, RED 33 (CI 17200), BLUE 1 (CI 42090).

  • Questions or Comments

    You may report an adverse reaction to: Maesa LLC c/o Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.

  • SPL UNCLASSIFIED SECTION

    Dist. by Maesa LLC, Los Angeles, CA 90024

  • PRINCIPAL DISPLAY PANEL - 384 mL Bottle Label

    HAIRITAGE
    by Mindy McKnight

    wash it away

    ANTI-DANDRUFF SHAMPOO
    FOR OILY, FLAKY SCALP

    SLS & SLES FREE
    PHTHALATE FREE
    PARABEN FREE
    SILICONE FREE
    GLUTEN FREE
    MINERAL OIL FREE
    COLOR SAFE
    CRUELTY FREE
    VEGAN

    DERMATOLOGIST TESTED & pH OPTIMIZED

    13 fl. oz. / 384 mL

    Principal Display Panel - 384 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAIRITAGE WASH IT AWAY ANTI-DANDRUFF FOR OILY, FLAKY SCALP 
    selenium sulfide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71899-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q) Selenium Sulfide1 mg  in 384 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    AMMONIUM LAURETH-12 SULFATE (UNII: E1ZP93931S)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    Ammonium Sulfate (UNII: SU46BAM238)  
    Ammonium Chloride (UNII: 01Q9PC255D)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Trisodium Nitrilotriacetate (UNII: E3C8R2M0XD)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Glyoxal (UNII: 50NP6JJ975)  
    Formic Acid (UNII: 0YIW783RG1)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71899-069-01384 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H04/06/2023
    Labeler - Maesa, LLC. (144282311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa255106239MANUFACTURE(71899-069)