Label: 2 IN 1 DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 55910-311-15, 55910-311-21, 55910-311-86
  • 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 February 13, 2017

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

  • claims

    Dandruff Shampoo

    Pyrithione Zinc 1%

    Simply Clean

    Multiple Benefit formula to help:

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

    Pyrithione Zinc 1%

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  • Purpose

    Anti-dandruff

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  • Use

    helps prevent recurrence of flaking and itching associated with dandruff

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  • Warnings

    For external use only

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  • When using this product

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

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

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

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  • Directions

    • shake well
    • for maximum dandruff controll, 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
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  • 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

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  • claims

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

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  • Adverse Reactions

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100% Satisfaction

    Guaranteed!

    (888)309-9030

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  • Principal Display Panel

    DG body

    2 in 1

    Dandruff Shampoo

    + Conditioner

    Pyrithione Zinc 1%

    Simply Clean

    Compare to Head & Shoulders

     2 in 1 Classic Clean Dandruff

    Shampoo + conditioner

    • For normal/oily hair
    • Cleans and conditions hair in one easy step

    33.9 FL OZ (1 L)

    image description

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  • INGREDIENTS AND APPEARANCE
    2 IN 1 DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-311
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-311-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/23/2005
    2 NDC:55910-311-21 88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/23/2005
    3 NDC:55910-311-86 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/23/2005
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 06/23/2005
    Labeler - Dolgencorp, LLC (068331990)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(55910-311)
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