Cystotone (Sarsaparilla, Uva-Ursi, Arsenicum Album, Cantharis, Pareira Brava, Pulsatilla, Sepia, Terebinthina, Populus Tremuloides) Liquid [Apotheca Company] -

CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]
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NDC	57520-0417-1
Set ID	39f263e4-35bc-4501-9ca9-937e97aef90d
Category	HUMAN OTC DRUG LABEL
Packager	Apotheca Company
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Sarsaparilla 3X, Uva-ursi 3X, Arsenicum album 12X, Cantharis 12X, Pareira brava 12X, Pulsatilla 12X, Sepia 12X, Terebinthina 12X, Populus tremuloides 15X.
PURPOSE

INDICATIONS: For temporary relief of intolerable urging and tenesmus, pressure in the area of the bladder, urination often.
WARNINGS

WARNINGS: If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
DOSAGE & ADMINISTRATION

SUGGESTED USE: Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.
INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol
QUESTIONS

Dist. By:

Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078
PRINCIPAL DISPLAY PANEL

ENERGIQUE

CYSTOTONE

Homeopathic Remedy

1 fl. oz.(30 ml)

INGREDIENTS AND APPEARANCE

CYSTOTONE
sarsaparilla, uva-ursi, arsenicum album, cantharis, pareira brava, pulsatilla, sepia, terebinthina, populus tremuloides liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0417
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SARSAPARILLA	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 TRIOXIDE - UNII:S7V92P67HO)	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
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	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
POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0)	POPULUS TREMULOIDES LEAF	15 [hp_X] in 1 mL
TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G)	TURPENTINE	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0417-1	30 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/17/2010

Labeler - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture

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Medic

CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [APOTHECA COMPANY]

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