Label: 2 IN 1- 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 September 12, 2022

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

View All Sections
  • Active Ingredient.

    PYRITHIONE ZINC (1%)

  • Purpose

    Anti dandruff

  • Uses

    To prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only

    When using this product

    Avoid contact with 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 of this product as directed.

    Keep out of reach of children.

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

  • Directions

    • For best resuts, use at least twice a week or as directed by a doctor.
    • For maximum dandruff control, use every time you shampoo.
    • Wet hair, massage onto scalp and rinse. Repeat if desired.
  • Other Information

    Store at room temperature

  • Inactive Ingredients

    Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Acrylates Copolymer, Glycol Distearate, Cocamidopropyl Betaine, Laureth-4, Dimethicone, Fragrance (Parfum), Cocamide MEA, Guar Hydroxypropyltrmonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Red 33 (Cl 17200).

  • Principal Display Panel

    PP04

  • INGREDIENTS AND APPEARANCE
    2 IN 1 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-027
    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
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    LAURETH-4 (UNII: 6HQ855798J)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71141-027-04420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/12/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/12/2021
    Labeler - LIDL US LLC (079389709)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(71141-027)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!