Label: DANDRUFF- pyrithione zinc lotion/shampoo

  • NDC Code(s): 41520-311-15, 41520-311-35
  • Packager: American Sales Company
  • 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 15, 2017

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

  • claims

    Multiple benefit formula to help:

    • Fight dry scalp
    • Calm itch
    • Relieve irritation
    • Soothe and reduce redness
    • Redce 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 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
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  • 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, red 33

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  • Disclaimer

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

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  • Adverse reactions

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949  2016  S&S Brands, LLC

    Quality guaranteed or your money back.

    311.007/311AK

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  • Principal Display Panel

    CAREONE

    everyday clan 2 in 1

    Dandruff

    shampoo

    plus conditioner

    for normal hair

    pyrithione zinc

    helps prevent flakes

    Compare to Head & Shoulders

    2 in 1 Classic Clean Dandruff

    Shampoo + Conditioner

    14.2 FL OZ (420 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc lotion/shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-311
    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:41520-311-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/09/2004
    2 NDC:41520-311-35 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/09/2004
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 07/09/2004
    Labeler - American Sales Company (809183973)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(41520-311)
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