Label: HEAD AND SHOULDERS MENTHOL FRESH- pyrithione zinc lotion/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 January 24, 2013

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

View All Sections
  • WARNINGS AND PRECAUTIONS

    Drug Facts

  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only.

  • 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.
  • 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 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.

  • 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.

  • Questions (or comments)?

    01-800-717-2413

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  MENTHOL FRESH
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51769-134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    sodium laureth sulfate (UNII: BPV390UAP0)  
    glycol distearate (UNII: 13W7MDN21W)  
    zinc carbonate (UNII: EQR32Y7H0M)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium xylenesulfonate (UNII: G4LZF950UR)  
    dimethicone (UNII: 92RU3N3Y1O)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    sodium benzoate (UNII: OJ245FE5EU)  
    magnesium carbonate hydroxide (UNII: YQO029V1L4)  
    methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    methylisothiazolinone (UNII: 229D0E1QFA)  
    POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Magnesium Sulfate (UNII: DE08037SAB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Sodium Xylenesulfonate (UNII: G4LZF950UR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51769-134-40400 mL in 1 BOTTLE, PLASTIC
    2NDC:51769-134-70700 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/24/2013
    Labeler - ALL NATURAL DYNAMICS (962732892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Procter & Gamble Manufactura, S. de R.L. de C.V.812807550manufacture(51769-134)
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!