Label: HEAD AND SHOULDERS REFRESHING RELIEF- head and shoulders 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 14, 2022

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  • Purpose

    With refreshing ingredients for immediate sensation

    *up to 100% dandruff free

    With Regular use, H&S 3action formula cleans, protects and hydrates hair and scalf.

    Head and Shoulders Refreshing Relief with balanced PH contains ingredients that in contact with the skin unleash refreshing sensations that immediate reduce the itching related to dandruff

    *Visible dandruff, using it often.

  • Active Ingredient

    Active Ingredient................................................................................Purpose

    Pyrithione Zinc 1%.....................................................................Anti-dandruff

  • Indications:

    helps prevent recurrence of flaking and itching associated with dandruff

  • Warnings

    for external use only.

  • When using this product

    -do not get into eyes. If contact occurs, rinse thoroughly with water

  • Stop use and ask doctor if

    condition worsens or does not improve after regular use as directed

  • Keep our of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    -shake well before use - apply in wet hair - massage into scalp - rinse

    -repeat as desired

    -for best results use at least twice a week or as directed by a doctor

    -for maximum dandruff control, use every time you shampoo

  • Inactive Ingredients

    Water, Sodium Laureth Sulfate,Sodium Lauryl Sulfate, Cocamide MEA, Zinc Carbonate,

    Glycol distearate,sodium xylenesulfonate, Fragrance, Dimethicone, Cetyl Alcohol, Guar Hydroxypropyltrimonium Chloride,

    Hydrochloric Acid, Magnesium Sulfate, Sodium Chloride, Sodium Benzoate, Magnesium Carbonate Hydroxide,

    Hexyl Cinnamal, Benzyl Alcohol, Mentha Piperita Oil, Menthol, Mentha arvensis leaf oil, Hydroxycitronellal, Linalool,

    FD&C Yellow No. 5, Methylisothiaolinone, FD&C Blue No. 1

  • Distributed by:

    ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.

    Made in Mexico

  • HEAD & SHOULDERS Antidandruff Shampoo REFRESHING RELIEF

    Refreshing Relief

    Refreshing Relief

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS REFRESHING RELIEF 
    head and shoulders lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72389-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    LINALOOL, (-)- (UNII: 3U21E3V8I2)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72389-108-02375 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/2018
    2NDC:72389-108-03180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/27/2018
    Labeler - ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. (812839648)
    Registrant - ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. (815333653)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROCTER & GAMBLE MANUFACTURING MEXICO, S. DE R.L. DE C.V.812807550manufacture(72389-108)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.812839648label(72389-108)
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