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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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  • ACTIVE INGREDIENT

    PYRITHIONE ZINC 1%

    PURPOSE

    ANTI-DANDRUFF

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  • USES

    TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF.

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  • 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.

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  • DIRECTIONS

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

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  • 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).

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  • QUESTIONS OR COMMENTS?

    1-877-932-7948

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  • LABEL COPY
  • INGREDIENTS AND APPEARANCE
    EQUALINE  CLASSIC CLEAN 2 IN 1
    pyrithione zinc liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41163-417
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    SODIUM LAURYL SULFATE  
    COCO MONOETHANOLAMIDE  
    ZINC CARBONATE  
    GLYCOL DISTEARATE  
    DIMETHICONE  
    CETYL ALCOHOL  
    POLYQUATERNIUM-10 (400 CPS AT 2%)  
    MAGNESIUM SULFATE  
    SODIUM BENZOATE  
    MAGNESIUM CARBONATE HYDROXIDE  
    AMMONIUM LAURETH-3 SULFATE  
    BENZYL ALCOHOL  
    SODIUM CHLORIDE  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    SODIUM XYLENESULFONATE  
    FD&C BLUE NO. 1  
    FD&C RED NO. 4  
    D&C YELLOW NO. 10  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-417-24 700 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 02/14/2013
    Labeler - SUPERVALU INC. (006961411)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    Name Address ID/FEI Business Operations
    APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41163-417)
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