SOOTHEX - sulfur, tea tree oil, witch hazel, eucalyptus globulus leaf, aloe vera leaf, calendula officinalis flower, methyl salicylate, vitamin a, and vitamin e cream SCA NuTec 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. ---------- Soothex 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 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 FOR USE ON ANIMALS ONLY 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] 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 T ype PRESCRIPTION ANIMAL DRUG Ite m Code (Source ) NDC:52338 -6 6 7 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 10 0 mg SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 ) SULFUR in 1 mL 10 mg TEA TREE O IL (UNII: VIF56 5UC2G) (TEA TREE OIL - UNII:VIF56 5UC2G) TEA TREE OIL in 1 mL EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 ) (EUCALYPTUS GLOBULUS EUCALYPTUS GLOBULUS 20 mg LEAF - UNII:S546 YLW6 E6 ) LEAF in 1 mL 20 mg WITCH HAZEL (UNII: 10 1I4J0 U34) (WITCH HAZEL - UNII:10 1I4J0 U34) WITCH HAZEL in 1 mL 15 mg 15 mg ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) (ALOE VERA LEAF - UNII:ZY8 1Z8 3H0 X) ALOE VERA LEAF in 1 mL CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD) (CALENDULA CALENDULA 25 mg OFFICINALIS FLOWER - UNII:P0 M7O4Y7YD) OFFICINALIS FLOWER in 1 mL 10 0 0 [iU] VITAMIN A (UNII: 8 1G40 H8 B0 T) (VITAMIN A - UNII:8 1G40 H8 B0 T) VITAMIN A in 1 mL METHYL SALICYLATE (UNII: LAV5U50 22Y) (METHYL SALICYLATE - METHYL SALICYLATE 2 mg in 1 mL UNII:LAV5U50 22Y) 2.6 mg VITAMIN E (UNII: H4N8 55PNZ1) (VITAMIN E - UNII:H4N8 55PNZ1) VITAMIN E in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52338 -6 6 7-20 20 0 0 0 mL in 1 BOTTLE Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date unappro ved drug o ther 0 4/0 1/20 10 Labeler - SCA NuT ec (233072193) Establishment Name Addre ss ID/FEI Busine ss Ope rations SCA NuTec 2330 7219 3 manufacture Revised: 4/2010 SCA NuTec.