Label: ULTRA- ambrosia artemisiaefolia, anacardium orientale, baryta muriatica, calcarea carbonica, calcarea phosphorica, fucus vesiculosus, helleborus niger, hypothalamus, ignatia amara, lycopodium clavatum, magnesia phosphorica, manganum metallicum, nicotinamidum, phosphorus, secale cornutum, silicea, solidago virgaurea, thymus serpyllum, thyroidinum liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55924-0001-1 - Packager: Soza Clinic
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated May 29, 2013
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DOSAGE & ADMINISTRATION
Directions: Swirl or shake bottle 5 times prior to use. Apply three sprays under the tongue twice daily, upon awakening and before sleeping. Do not eat, drink, or brush your teeth within 5 minutes before or after taking this remedy. Consult a physician prior to use in children under 15 years of age.
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WARNINGS AND PRECAUTIONS
Warnings: Stop use and ask a doctor if symptoms persist or worsen. In case of overdose, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, take only on advice of physician. Keep out of reach of children.
Other Information: Store in a cool dry place. Tamper resistant for you protection. Use only if safety seal is intact.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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ACTIVE INGREDIENT
Active Ingredients: The following ingredients at 10X potency: Ambrosia artemisiaefolia, Anacardium orientale, Baryta muriatica, Calcarea carbonica, Calcarea phosphorica, Fucus Vesiculosus, Helleborus niger, Hypothalamus, Ignatia amara, Lycopodium clavatum, Magnesia phosphorica, Manganum metallicum, Nicotinamidum, Phosphorus, Secale Cornutum, Silicea, The following ingredients at 12X potency Solidago virgaurea, Thymus serpyllum, Thyroidinum.
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTRA
ambrosia artemisiaefolia, anacardium orientale, baryta muriatica, calcarea carbonica, calcarea phosphorica, fucus vesiculosus, helleborus niger, hypothalamus, ignatia amara, lycopodium clavatum, magnesia phosphorica, manganum metallicum, nicotinamidum, phosphorus, secale cornutum, silicea, solidago virgaurea, thymus serpyllum, thyroidinum liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55924-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA 10 [hp_X] in 29.6 mL SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 10 [hp_X] in 29.6 mL BARIUM CHLORIDE DIHYDRATE (UNII: EL5GJ3U77E) (BARIUM CATION - UNII:V645272HLN) BARIUM CHLORIDE DIHYDRATE 10 [hp_X] in 29.6 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 29.6 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 10 [hp_X] in 29.6 mL FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS 10 [hp_X] in 29.6 mL HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT 10 [hp_X] in 29.6 mL BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS 10 [hp_X] in 29.6 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 10 [hp_X] in 29.6 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 10 [hp_X] in 29.6 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 29.6 mL MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P) MANGANESE 10 [hp_X] in 29.6 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 10 [hp_X] in 29.6 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 29.6 mL CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM 10 [hp_X] in 29.6 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [hp_X] in 29.6 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 12 [hp_X] in 29.6 mL THYMUS SERPYLLUM (UNII: 86H4S6K51N) (THYMUS SERPYLLUM - UNII:86H4S6K51N) THYMUS SERPYLLUM 12 [hp_X] in 29.6 mL THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED 12 [hp_X] in 29.6 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55924-0001-1 29.6 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/03/2013 Labeler - Soza Clinic (078738696) Registrant - Soza Clinic (078738696) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 api manufacture(55924-0001)
