Label: CYSTOTONE- sarsaparilla, uva-ursi, arsenicum album, cantharis, pareira brava, pulsatilla, sepia, terebinthina, populus tremuloides liquid
- NDC Code(s): 44911-0086-1
- Packager: Energique, Inc.
- Category: HUMAN OTC 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 March 10, 2022
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
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INGREDIENTS AND APPEARANCE
CYSTOTONE
sarsaparilla, uva-ursi, arsenicum album, cantharis, pareira brava, pulsatilla, sepia, terebinthina, populus tremuloides liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0086 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT 3 [hp_X] in 1 mL ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF 3 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 12 [hp_X] in 1 mL CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) ANEMONE PULSATILLA 12 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 12 [hp_X] in 1 mL TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F) TURPENTINE OIL 12 [hp_X] in 1 mL POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID) POPULUS TREMULOIDES BARK 15 [hp_X] in 1 mL POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF 15 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0086-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/18/2017 02/28/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/15/2013 02/28/2024 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0086) , api manufacture(44911-0086) , label(44911-0086) , pack(44911-0086)