Label: SCALPICIN ANTI-ITCH MAXIMUM STRENGTH- hydrocortisone liquid

  • 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 January 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch liquid

  • Uses

    • temporarily relieves itching associated with minor skin irritations and rashes due to
      • seborrheic dermatitis
      • eczema
      • psoriasis
    • other uses of this product should be only under the advice and supervision of a doctor
  • 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, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor

    Do not use for the treatment of diaper rash. Consult a doctor.

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

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use; consult a doctor
    • twist the flow-control cap to open
    • apply at first signs of itching
    • if using after shampooing, towel dry hair
    • apply from bottle directly to scalp, massage in
    • to avoid running or dripping, do not squeeze bottle too hard
  • Other information

    • store at 20-25 °C (68-77°F)
    • protect from humidity
    • flammable. Keep away from fire, flame or heat.
    • keep carton for full product information
  • Inactive ingredients

    Alcohol Denat., Aloe Barbadensis Leaf Juice, Dipropylene Glycol, Disodium EDTA, Glycerin, Melaleuca Alternifolia Leaf Oil, Menthol, PEG-40/PPG-8 Methylaminopropyl/Hydroxypropyl Dimethicone Copolymer, Propylene Glycol, t-Butyl Alcohol, Tocopheryl Acetate, Water

  • Questions?

    1-866-252-5327

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by: RB Health (US)
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 44 mL Bottle Carton

    SCALPICIN ®

    MAXIMUM

    STRENGTH

    Hydrocortisone 1% Anti-Itch Liquid

    SCALP ITCH RELIEF

    on the GO

    WITH ALOE

    1.5 FL OZ (44 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    SCALPICIN  ANTI-ITCH MAXIMUM STRENGTH
    hydrocortisone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-851
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-851-151 in 1 CARTON10/15/2012
    144 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/15/2012
    Labeler - RB Health (US) LLC (081049410)
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