Label: BASIC ESSENTIALS DANDRUFF DRY SCALP- pyrithione zinc 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 June 10, 2015

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  • ACTIVE INGREDIENT


    Active Ingredient                                     Purpose

    Zinc Pyrithione       1%                            Anti-dandruff


  • PURPOSE

    Helps prevent recurrence of flaking and itching associated with dandruff.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

    Do not get into eyes, if contact occurs, rinse eyes thoroughly with water.

  • INDICATIONS & USAGE

    Shake well, wet hair, massage onto scalp. Rinse, repeat if desired.

    For best results, use at least twice a week or as directed by a doctor.

    For maximum dandruff control, use every time you shampoo.

  • WARNINGS

    For external use only.

    Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.

  • DOSAGE & ADMINISTRATION

    apply as needed.

  • INACTIVE INGREDIENT

    water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, red 4

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    BASIC ESSENTIALS DANDRUFF  DRY SCALP
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-607
    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)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    glycol stearate (UNII: 0324G66D0E)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ammonium chloride (UNII: 01Q9PC255D)  
    methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    methylisothiazolinone (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50438-607-01420 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/10/2015
    Labeler - Filo America (943873703)
    Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265manufacture(50438-607)
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