Label: HAIRSANITY STEP 1- hydrocortisone acetate shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 26, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone acetate 0.5%

  • Purpose

    Antipruritic

  • Uses

    • for the temporary relief of itching associated with minor skin irritations and rashes.
  • Warnings

    For external use only.

    Avoid contact with the eyes.

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

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

  • Directions

    Apply a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. Add additional water and cleanser for increased lather. Massage lather into scalp and rinse thoroughly with warm water. Use daily or minimum of 3 times per week. Children under 2 years of age: do not use, consult a doctor. Store at room temperature.

  • Inactive ingredients

    Water, Sodium Lauroyl Methyl Isethionate, Acrylates Copolymer, Decyl Glucoside, Sodium Lauroamphoacetate, Sodium Methyl Cocoyl Taurate, Sodium Cocoyl Isethionate, Butylene Glycol, Glycereth-26, Cocamidopropyl Betaine, Fragrance, Glycerin, Glycol Stearate, Phenoxyethanol, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Allantoin, BHT, Disodium EDTA, Ethylhexylglycerin, Caprylic/Capric Triglyceride, Methylpropanediol, 4-Terpineol, Isomalt, Rhododendron Ferrugineum Leaf Cell Culture Extract, Lecithin, Lactic Acid, Salicylic Acid, Sea Whip Extract, Salix Alba (Willow) Bark Extract, Menthol, Benzyl Alcohol, Isopropyl Palmitate, Polyglyceryl-4 Laurate, Poloxamer 407, Citric Acid

  • PRINCIPAL DISPLAY PANEL - 89 mL Tube Label

    HAIR
    SANITY

    STEP 1

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

    ANTI-ITCH SHAMPOO
    for beautiful, more manageable,
    and softer hair.
    Hydrocortisone Acetate

    3 FL OZ (89 mL)

    Principal Display Panel - 89 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    HAIRSANITY STEP 1 
    hydrocortisone acetate shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71605-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    4-TERPINEOL, (+)- (UNII: HZK34LN80N)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ISOMALT (UNII: S870P55O2W)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71605-000-01237 mL in 1 TUBE; Type 0: Not a Combination Product08/10/2017
    2NDC:71605-000-0489 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 NOT FINALpart34808/10/2017
    Labeler - H Plus Holdings (080731249)