Label: 2 IN 1 DANDRUFF- 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 21, 2018

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

  • claims

    Dandruff 2 IN 1

    Everyday Clean

    Dandruff Care for Great Looking Hair.

    Helps relieve scalp dryness, itch,

    irritation and helps prevent flakes.

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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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  • Questions

    Call 1-888-593-0593

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  • Adverse Reactions Section

    MADE WITH PRIDE AND CARE FOR H-E-B,

    SAN ANTONIO, TX 78204

    100% GUARANTEE

    promise

    If you aren't completely pleased with this product,

    we'll be happy to replace it or refund your money.

    You have our word on it

    311.007/311AK-AL

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  • Principal Display Panel

    H-E-B

    Dandruff

    2 in 1

    Shampoo + Conditioner

    With Pyrithione Zinc

    EVERYDAY CLEAN

    FOR NORMAL HAIR

    Leaves Hair

    Healthy Looking &

    Fights Dry Scalp

    14.2 FL OZ (420 mL)

    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:37808-311
    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:37808-311-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/15/2009
    2 NDC:37808-311-35 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/15/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 05/15/2009
    Labeler - HEB (007924756)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(37808-311)
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