DANDRUFF (PYRITHIONE ZINC) SHAMPOO [HEB]

DANDRUFF (PYRITHIONE ZINC) SHAMPOO [HEB]
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NDC 37808-070-15
Set ID 0927361e-a210-4e44-bbe7-fb68b240cf4f
Category HUMAN OTC DRUG LABEL
Packager HEB
Generic Name
Product Class
Product Number
Application Number PART358H
  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching assocaited 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, sodim benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • SPL UNCLASSIFIED SECTION

    DANDRUFF 2 IN 1
    OCEAN BREEZE SCENT
    Dandruff Care for Great Lookingh Hair.
    Helps relieve scalp dryness, itch, irritation and helps prevent flakes

    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 repla it or refund your money. You have our word on it.

  • PRINCIPAL DISPLAY PANEL

    H-E-B

    DANDRUFF 2 IN 1 SHAMPOO & CONDITIONER WITH PYRITHIONE ZINC

    OCEAN BREEZE SCENT

    AN ENERGIZING CLEAN

    Leaves Hair Healthy Looking & Fights Dry Scalp

    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-070-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/21/2016
    Labeler - HEB (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-070)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-070)

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