Label: CLEAR 2 IN 1 SCALP COMFORT ANTIDANDRUFF- 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 April 23, 2014

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient

    PYRITHIONE ZINC (1.0%)

  • PURPOSE

    Purpose

    Anti-Dandruff

  • INDICATIONS & USAGE

    Use  Helps prevent and control recurrence of itching and flaking associated with dandruff

  • WARNINGS

    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 this and all drugs out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hair, massage into scalp.  Repeat if desired.  For best results use at least twice a week or as directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

  • QUESTIONS

    Questions, Comments?

    1-800-372-6389

  • 12.9 FL OZ PDP

    ClearMen2in1ScalpComfortADPDP

  • 12.9 FL OZ back

    ClearMen2in1ScalpComfortADPDPback

  • INGREDIENTS AND APPEARANCE
    CLEAR  2 IN 1 SCALP COMFORT ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAUROYL ISETHIONATE (UNII: M590021Z02)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PPG-9 (UNII: I29VQH0G0B)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    LAURETH-23 (UNII: N72LMW566G)  
    LAURETH-4 (UNII: 6HQ855798J)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    POLYETHYLENE GLYCOL 400000 (UNII: 439X29GCJZ)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TALLOW ACID, BEEF (UNII: 5U9XZ261ER)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1309-1647 mL in 1 CONTAINER
    2NDC:64942-1309-2381 mL in 1 CONTAINER
    3NDC:64942-1309-350 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/01/2013
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture(64942-1309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marietta Corp111359712manufacture(64942-1309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marietta Corp010765394manufacture(64942-1309)
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!