Label: 2 IN 1 DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 21130-942-15, 21130-942-35
  • Packager: Living Better Brands LLC
  • 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 8, 2022

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  • claims

    2 in 1

    Dandruff Shampoo plus

    Conditioner

  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff

  • Warnings

    For external use only

  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • condition worsens or does not improve after regular use as directed
  • Keep  out of reach of children

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

  • Directions

    • shake well
    • for maximum dandruff control, use every time you shampoo
    • wet hair, massage onto scalp, rinse, repeat if desired
    • for best results use at least twice a week or as directed by a doctor
  • inactive ingredients

    water, sodium lauryl sulate, sodium laureth, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • disclaimer

    This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders Classic Clean 2 in 1

  • Adverse Reactions

    DISTRIBUTED BY BETTER LIVING BRANDS LLC

    P.O. BOX 99, PLEASANTON, CA 94566-0009

    1-888-723-3929 www.letterlivingbrandsLLC.com

    OUR PROMISE, QUALITY & SATISFACTION 100%

    GUARANTEED OR YOUR MONEY BACK

  • principal display panel

    Compare to Olay Complete All Day Moisture Lotion SPF 15

    complete

    beauty

    lotion

    all day

    moisturizer

    Broad Spectrum SPF 15

    Sunscreen

    with vitamin E and aloe

    Sensitive Skin

    light and non-greasy lotion

    ShopRite

    4 FL OZ (118 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    2 IN 1 DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-942
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-942-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2006
    2NDC:21130-942-35700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/11/2006
    Labeler - Living Better Brands LLC (009137209)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(21130-942)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(21130-942)
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