Spigelia comp

SPIGELIA COMP- spigelia comp liquid
Uriel Pharmacy Inc.

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.

----------

Spigelia comp

Directions: FOR ORAL USE.

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

Active Ingredients: Aconitum (Monkshood) 8X, Arnica 8X, Natrium nitrosum (Sodium nitrite) 8X, Spigelia (Pinkroots) 8X, Argentum nitricum (Silver nitrate) 10X, Phosphorus (Yellow phosphorus) 12X

Inactive Ingredients: Water, Salt

Use: Temporary relief of headache.

KEEP OUT OF REACH OF CHILDREN.

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

Questions? Call 866.642.2858
Made by Uriel, East Troy, WI 53120
www.urielpharmacy.com Lot:

Spigelia comp

SPIGELIA COMP
spigelia comp liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48951-8368
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	8 [hp_X] in 1 mL
SODIUM NITRITE (UNII: M0KG633D4F) (NITRITE ION - UNII:J39976L608)	NITRITE ION	8 [hp_X] in 1 mL
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	8 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL
SPIGELIA MARILANDICA ROOT (UNII: 467D26HS0B) (SPIGELIA MARILANDICA ROOT - UNII:467D26HS0B)	SPIGELIA MARILANDICA ROOT	8 [hp_X] in 1 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:48951-8368-1	10 in 1 BOX	09/01/2009
1		1 mL in 1 AMPULE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/01/2009

Labeler - Uriel Pharmacy Inc. (043471163)

Name	Address	ID/FEI	Business Operations
Establishment
Uriel Pharmacy Inc.		043471163	manufacture(48951-8368)