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 January 3, 2019

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

  • 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 by a doctor
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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, yellow 5

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  • Questions?

    Call 1-888-593-0593

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  • SPL UNCLASSIFIED SECTION

    Dandruff 2 in 1 Clean Apple

    Dandruff Care for Great Looking Hair.
    Helps relieve scalp dryness, itch, irritation and helps prevent flakes.

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

    SAN ANTONIO, TX 78204

    100% GUARANTEE

    If you aren't completely pleased with this product, we'll be happt to replace it or refund your money.  You have our word on it.

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  • Principal display panel

    H-E-B

    Dandruff 2 in 1 Shampoo & Conditioner

    With Pyrithione Zinc

    CLEAN APPLE

    REFRESHING AND CLEAN

    Leaves Hair Healthy Looking & Fights Dry Scalp

    23.7 FL OZ (1.4 PT) 700 mL

    image description

    612.001/612AC

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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:37808-612
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g  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)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-612-35 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/19/2016
    2 NDC:37808-612-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/19/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 10/19/2016
    Labeler - H E B (007924756)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(37808-612)
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