ENURESIS- equisetum hyemale, solidago virgaurea flowering top, arctostaphylos uva-ursi leaf, silver, causticum, nitric acid, sepia officinalis juice, thuja occidentalis leafy twig and wood creosote liquid
Apotheca Company

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.

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Drug Facts:

ACTIVE INGREDIENTS: Equisetum hyemale 3X, Solidago virgaurea 3X, Uva-ursi 3X, Argentum metallicum 12X, Causticum 12X, Kreosotum 12X, Nitricum acidum 12X, Sepia 12X, Thuja occidentalis 12X.

INDICATIONS: For temporary relief of involuntary urination after falling asleep at night, and hurrying when desire comes to urinate.

WARNINGS: If pregnant or breast-feeding, ask a health care 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.

DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS: For temporary relief of involuntary urination after falling asleep at night, and hurrying when desire comes to urinate.

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

ENURESIS

1 FL OZ (30 ml)

Enuresis

ENURESIS
equisetum hyemale, solidago virgaurea, uva-ursi, argentum metallicum, causticum, kreosotum, nitricum acidum sepia thuja occidentalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0511
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	3 [hp_X] in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	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
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	12 [hp_X] in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X] in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	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
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	12 [hp_X] in 1 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	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:57520-0511-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/15/2010	06/23/2015

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0511) , api manufacture(57520-0511) , label(57520-0511) , pack(57520-0511)

Revised: 9/2015

Document Id: 8a1109f1-aa84-4732-aefa-e63500abd42a

Set id: 6d5d8f81-8bc0-48e3-8909-519bcf4e5e9e

Version: 3

Effective Time: 20150930

Apotheca Company