Label: CLASSIC CLEAN 2 IN 1 FOR NORMAL HAIR- 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 July 1, 2010

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  • ACTIVE INGREDIENT

    PYRITHIONE ZINC 1%

  • PURPOSE

    ANTI-DANDRUFF
  • WARNINGS

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THROUGHLY 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

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


  • Uses

    HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF
  • Directions

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

  • PACKAGE FRONT AND BACK LABELS

    14OZ Front and Back Labels: eq14.jpg14 OZ FRONT AND BACK LABELS

  • INGREDIENTS AND APPEARANCE
    CLASSIC CLEAN 2 IN 1  FOR NORMAL HAIR
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-415-14420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/01/2010
    Labeler - SUPERVALU INC (006961411)