Label: GRAHAMS NATURAL ECZEMA GEL- allantoin gel

  • 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 August 26, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients

    Allantoin 0.8%

  • PURPOSE

    Purpose

    Eczema, insect bites, minor cuts and burns

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Uses/Indications

    For the relief of the symptoms of eczema, insect bites, minor cuts and burns

  • DOSAGE & ADMINISTRATION

    Directions

    Apply to affected area as needed or as directed by a doctor

  • WARNINGS

    Warnings for external use only

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on

    • deep puncture wounds
    • serious burns
    • animal bites
    • broken skin
  • DESCRIPTION

    Grahams Natural Eczema Gel

    For the relief of eczema, insect bites, minor cuts and burns. 

    Natural soothing ingredients of comfrey, aloe vera, calendula, manuka honey.

    Nature at its Best

    Grahams Natural Eczema Gel is a soothing gel formulated for the relief of Eczema using natural ingredients of comfrey, aloe vera, calendula, along with the healing qualities of manuka honey

    steroid and fragrance free

  • 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

    aloe barbadensis leaf, aqua, manuka honey, centella asiatica, calendula, hamamelis virginiana leaf, matricaria recutita flower, polysorbate, phenoxyethanol, carbomer, potassium hydroxide.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    GRAHAMS NATURAL ECZEMA GEL 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42387-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    HONEY (UNII: Y9H1V576FH)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42387-300-0157 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/26/2015
    Labeler - Grahams Natural Alternatives Pty Ltd (742235419)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grahams Natural Alternatives Pty Ltd742235419manufacture(42387-300)
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