Bio-Wild Rose

Drug Labeling and Warnings

Drug Details [pdf]

BIO WILD ROSE- wild rose, 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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Bio-Wild Rose

ACTIVE INGREDIENTS:

Wild Rose 6X, 30C, 200C

INDICATIONS:For temporary relief of resignation,apathy.

WARNINGS:If pregnant or breastfeeding, ask a health care professional before use.

Keep out of the reach of children. In case of overdose, get medical attention 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:

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

INDICATIONS:For temporary relief of resignation, apathy.

DISTRIBUTED BY:

BIOACTIVE NUTRITIONAL

Melbourne, FL  32935

FOR NUTRITIONAL INFORMATION WRITE:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL  32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic
BIO WILD ROSE 6X, 30C, 200C
1 FL OZ (30 ml)

BIO WILD ROSE 
wild rose, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0846
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q)	ROSA CANINA FLOWER	6 [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: 57520-0846-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/04/2011	09/03/2019

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(57520-0846) , api manufacture(57520-0846) , label(57520-0846) , pack(57520-0846)

Revised: 12/2015

Document Id: 0f6228d9-da6d-45a2-9325-7129d443fa67

Set id: 8c3f0503-2b3b-4f79-a3ea-fff7cc20f740

Version: 2

Effective Time: 20151231