Label: EQUALINE CLASSIC CLEAN 2 IN 1- pyrithione zinc liquid

  • 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 February 14, 2013

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

View All Sections
  • ACTIVE INGREDIENT

    PYRITHIONE ZINC 1%

    PURPOSE

    ANTI-DANDRUFF

  • USES

    TO HELP 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 WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED.

  • INACTIVE INGREDIENTS:

    WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, FRAGRANCE (PARFUM), CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, BENZYL ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, SODIUM XYLENE SULFONATE, BLUE 1 (CI 42090), RED 4 (CI 14700), YELLOW 10 (CI 47005).

  • QUESTIONS OR COMMENTS?

    1-877-932-7948

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    EQUALINE  CLASSIC CLEAN 2 IN 1
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-417
    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 LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-417-24700 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/14/2013
    Labeler - SUPERVALU INC. (006961411)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41163-417)
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!