Label: HAIRSANITY STEP 2- salicylic acid 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 July 27, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 1.85%

  • Purpose

    Anti-Dandruff

  • Uses

    • helps prevent reoccurance of flaking and itching associated with dandruff.
  • Warnings

    For external use only.

    Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    If condition worsens, or does not improve after regular use of this product as directed, stop use of this product and consult a doctor.

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

  • Directions

    Gently massage into scalp and work through hair to the ends. Leave on 30 seconds for normal hair and 2-3 minutes for damaged and/or processed hair. Rinse with warm water, dry and style as usual. For best results use at least twice a week or as directed by a doctor. Store at room temperature.

  • Inactive ingredients

    Water, Cetyl Alcohol, Stearyl Alcohol, Glycereth-26, Dicetyldimonium Chloride, Bis-Cetearyl Amodimethicone, Behentrimonium Chloride, Butylene Glycol, Glycerin, Dimethicone, Distearyldimonium Chloride, Fragrance, Guar Hydroxypropyltrimonium Chloride, Phenoxyethanol, Sodium Hydroxide, Polysilicone-19, Allantoin, Caprylic/Capric Triglyceride, Algae Extract, Laminaria Digitata Extract, Tocopheryl Acetate, Ethylhexylglycerin, Methylpropanediol, Avena Sativa (Oat) Kernel Extract, 4-Terpineol, Isomalt, Rhododendron Ferrugineum Leaf Cell Culture Extract, Lecithin, Lactic Acid, Sea Whip Extract, Salix Alba (Willow) Bark Extract, Menthol, Benzyl Alcohol, Isopropyl Palmitate, Polyglyceryl-4 Laurate, Poloxamer 407

  • PRINCIPAL DISPLAY PANEL - 89 mL Tube Label

    HAIR
    SANITY    ™
    STEP 2

    REGULAR USE OF
    OUR 2 STEP SYSTEM
    WILL CHANGE THE
    WAY YOUR HAIR
    LOOKS AND FEELS
    FOREVER.

    ANTI-DANDRUFF CONDITIONER
    for beautiful, more manageable,
    and softer hair.
    Salicylic Acid

    3 FL OZ (89 mL)

    Principal Display Panel - 89 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    HAIRSANITY STEP 2 
    salicylic acid lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71605-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid18.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    DICETYLDIMONIUM CHLORIDE (UNII: 6F4SX2007N)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    OAT (UNII: Z6J799EAJK)  
    4-TERPINEOL, (+)- (UNII: HZK34LN80N)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ISOMALT (UNII: S870P55O2W)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71605-100-03237 mL in 1 TUBE; Type 0: Not a Combination Product08/10/2017
    2NDC:71605-100-0689 mL in 1 TUBE; Type 0: Not a Combination Product08/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H08/10/2017
    Labeler - H Plus Holdings (080731249)
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