Label: GRAHAMS NATURAL PSORIASIS AND DERMATITIS- salicylic acid cream

  • 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 September 3, 2015

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  • PURPOSE

    Purpose

    Psoriasis/Seborrheic Dermatitis

  • ACTIVE INGREDIENT

    Active Ingredients

    Salicylic Acid 2%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Uses/Indications

    For the relief of the symptoms of psoriasis and/or seborrheic dermatitis

  • DOSAGE & ADMINISTRATION

    Directions

    Apply to affected area 1-4 times daily or as directed by a doctor

  • WARNINGS

    Warnings for external use only

    If contact occurs, rinse eyes thoroughly with water

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

    If condition covers a large area of the body, consult your doctor before using this product.

  • DESCRIPTION

    Grahams Natural Psoriasis & Dermatitis Cream

    Grahams Natural Psoriasis and Dermatitis Cream is a unique formulation using the soothing benefits of calendula, gotu kola and propolis along with the healing qualities of manuka honey.

    steroid and fragrance free

    Nature at its Best

  • QUESTIONS

    Other Information

    Store below 86F or 30C

    For best results use with Grahams Natural Bath Oil

    Questions  www.itchy.net.au

    Made in Australia

    Grahams Natural Alternatives Pty Ltd

    7 Palings Crt, Nerang, QLD 4211 Australia

  • INACTIVE INGREDIENT

    Inactive Ingredients

    aqua, cetostearyl alcohol, calendula officinalis, centella asiatica, manuka honey, propolis, cetomacrogol, phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GRAHAMS NATURAL PSORIASIS AND DERMATITIS 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42387-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    HONEY (UNII: Y9H1V576FH)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    CETETH-20 (UNII: I835H2IHHX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42387-200-0157 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/01/2015
    Labeler - Grahams Natural Alternatives Pty Ltd (742235419)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grahams Natural Alternatives Pty Ltd742235419manufacture(42387-200)
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