Label: LOESCH ANTI-ITCH THERAPY- hydrocortisone liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 26, 2014

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  • Active Ingredient

    Hydrocortisone, USP (0.5%)

  • Purpose

    Anti-Itch

  • Use

    • Specially formulated to rapidly and completely penetrate the scalp (or skin) delivering itch relief anywhere it's needed.
    • This liquid preparation can be applied to the skin or scalp to temporarily relieve minor itching and skin irritations commonly associated with insect bites, poison oak, poison sumac, and skin blemishes.
  • Warnings

    • Not for use on children under 2 years old except as directed by a pediatrician.
    • Avoid contact with eyes and mucous membranes.
    • Do not apply to large areas of the body and do not use for extended periods of time.
    • For external use only.
    • If irritation develops and persists, discontinue use and ask a doctor.
    • When using this product, if condition worsens or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use and ask a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    • Apply this product topically to affected areas and allow to dry without rubbing.
    • Use up to 3 times daily.
    • Use only as directed.
  • Other Information

    • External antipruritic
  • Inactive Ingredients:

    Ethanol, Purified Water, Isopropyl Alcohol, Glycerin, Laureth 4, t-Butyl Alcohol, Brucine Sulfate

  • Questions or Comments?

    Loesch Laboratory Consultants, Inc.
    4311 South Dr., Houston, TX 77053-4820
    800.231.7157 M-F 8am-5pm

  • Image of 2.0 Fl. Oz. LabelNDC:25280-004-02

    LoeschAntiItchTherapy2oz.jpgLabel

  • INGREDIENTS AND APPEARANCE
    LOESCH  ANTI-ITCH THERAPY
    hydrocortisone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25280-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-4 (UNII: 6HQ855798J)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    BRUCINE SULFATE (UNII: KY7O12XPOQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25280-004-0259.147 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/26/2014
    Labeler - Loesch Laboratory Consultants, Inc. (026619510)
    Registrant - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(25280-004)
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