Label: HEAD AND SHOULDERS MENTHOL FRESH- pyrithione zinc lotion/shampoo 

  • NDC Code(s): 51769-133-40, 51769-133-70
  • Packager: ALL NATURAL DYNAMICS
  • 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 01/13

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  • WARNINGS AND PRECAUTIONS

    Drug Facts

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  • Active ingredient

    Pyrithione zinc 1%

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  • Purpose

    Anti-dandruff

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  • Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

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  • Warnings

    For external use only.

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  • Directions

    • for best results 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, rinse, repeat if desired.
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  • When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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  • Stop use and ask a doctor if

    condition worsens or does not improve after regular use of this product as directed.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • Inactive ingredients

    Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, pyrithione zinc, blue 1, red 33.

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  • Questions (or comments)?

    01-800-717-2413

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  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  MENTHOL FRESH
    pyrithione zinc lotion/shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51769-133
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pyrithione Zinc (PYRITHIONE ZINC) Pyrithione Zinc 0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    sodium lauryl sulfate  
    sodium laureth sulfate  
    glycol distearate  
    zinc carbonate  
    sodium chloride  
    sodium xylenesulfonate  
    dimethicone  
    cocamidopropyl betaine  
    sodium benzoate  
    magnesium carbonate hydroxide  
    methylchloroisothiazolinone  
    methylisothiazolinone  
    pyrithione zinc  
    FD&C blue no. 1  
    D&C red no. 33  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51769-133-40 400 mL in 1 BOTTLE, PLASTIC
    2 NDC:51769-133-70 700 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 01/24/2013
    Labeler - ALL NATURAL DYNAMICS (962732892)
    Establishment
    Name Address ID/FEI Business Operations
    Procter & Gamble Manufactura, S. de R.L. de C.V. 812807550 manufacture(51769-133)
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