Label: 2 IN 1 DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 55910-942-15, 55910-942-35
  • Packager: DOLGENCORP, 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 January 16, 2020

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  • 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 sulfate, sodium laureth sulfate, 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, yellow 5

  • SPL UNCLASSIFIED SECTION

    2 IN 1 Dandruff Shampoo + Conditioner Pyrithione Zinc 1%
    Green Apple
    Multiple benefit formula to help:

    • Fight dry scalp
    • Calm itch
    • Relieve irritation
    • Soothe and reduce redness
    • Reduce oilines
    • Prevent flakes
    • Leave hair healthy looking

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Green Apple 2 in 1 Dandruff Shampoo & conditioner.

    DISTRIBUTED BY DOLGENCORP, LLC
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072
    100% Satisfaction Guaranteed!
    (888)309-9030

  • principal display

    DG body 2 in 1 Dandruff Shampoo + Conditioner Pyrithione Zinc 1%

    Green Apple

    Compare to Head & Shoulders 2 in 1 Green Apple Dandruff Shampoo +Conditioner*

    • Battles dandruff with a refreshing clean scent
    • Cleans and condtions hair in one easy step

    23.7 FL OZ (700 mL)

    612.001/612AC

    image description

  • principal display panel

    STUDIO

    SELECTION

    2 IN 1

    DANDRUFF SHAMPOO

    & CONDITIONER

    PYRITHIONE ZINC 1%

    Compare to Head & Shoulders

    Green Apple 2 in 1 Dandruff

    Shampoo & Conditioner

    Battles dandruff

    with a refreshing

    & clean scent

    GREEN

    APPLE

    cleans and conditions 

    hair in one easy step

    23.7 FL OZ (700 mL

    image description

  • INGREDIENTS AND APPEARANCE
    2 IN 1 DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-942
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  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)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-942-35700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/18/2016
    2NDC:55910-942-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/18/2016
    Labeler - DOLGENCORP, LLC (068331990)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(55910-942)
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