Label: SOOTHEX- sulfur, tea tree oil, witch hazel, eucalyptus globulus leaf, aloe vera leaf, calendula officinalis flower, methyl salicylate, vitamin a, and vitamin e cream

  • Category: PRESCRIPTION ANIMAL DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 19, 2010

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  • SPL UNCLASSIFIED SECTION

    A Topical Cream for Equines

    Soothex is a complex formulation of botanical
    components inc Tea Tree Oil and sulfur plus
    vitamins A and E.
    SOTHEX IS FOR TOPICAL USE ONLY


  • SPL UNCLASSIFIED SECTION

    Soothex contains:
    Sulfur [precipitated]
    Calendula officinalis extract
    Mentha piperita, hamamelis virginia, eucalyptus glob.
    Aloe barbadensis, Melaleuca alternifolia
    Vitamin A, Methyl salicylate, Vitamin E plus excipients

  • WARNINGS

    FOR USE ON ANIMALS ONLY

  • SPL UNCLASSIFIED SECTION

    Soothex contains NO animal parts or residues

    Imported to the USA by :
    Emerald Valley Natural Health Inc, Exeter, NH 03833

    Batch No: 94430
    Use by Date : 03/12/11

    Soothex is manufactured in the UK by
    SCA Nutec [Provimi Ltd]
    Nutec Mill, Eastern Avenue
    Lichfield, Staffordshire, WS13 7SE, UK


    Exported by :
    Equiglobal Ltd
    Manningtree, Essex, CO11 1UT, UK

    20 Litres/5.283 gallons [US]
  • PRINCIPAL DISPLAY PANEL

    image of container

  • INGREDIENTS AND APPEARANCE
    SOOTHEX 
    sulfur, tea tree oil, witch hazel, eucalyptus globulus leaf, aloe vera leaf, calendula officinalis flower, methyl salicylate, vitamin a, and vitamin e cream
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:52338-667
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 mL
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL10 mg  in 1 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF20 mg  in 1 mL
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL20 mg  in 1 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF15 mg  in 1 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER25 mg  in 1 mL
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1000 [iU]  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE2 mg  in 1 mL
    VITAMIN E (UNII: H4N855PNZ1) (VITAMIN E - UNII:H4N855PNZ1) VITAMIN E2.6 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52338-667-2020000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2010
    Labeler - SCA NuTec (233072193)
    Establishment
    NameAddressID/FEIBusiness Operations
    SCA NuTec233072193manufacture