Apis Belladonna by Uriel Pharmacy Inc. APIS BELLADONNA cream

Apis Belladonna by

Drug Labeling and Warnings

Apis Belladonna by is a Homeopathic medication manufactured, distributed, or labeled by Uriel Pharmacy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION

Apply to skin as needed. Under age 2: Consult a doctor.

ACTIVE INGREDIENT

Active Ingredients: Echinacea (Purple coneflower) 2X, Kalium chlor. (Potassium chloride) 5X, Apis (Honeybee) 6X, Arnica 6X, Atropa belladonna (Nightshade) 7X, Bryonia (White bryony) 7X, Vivianite (Nat. ferrous phosphate) 9X, Lachesis (Bushmaster venom) 16X, Mercurius sol. (Mercury amidonitrate) 16X

INACTIVE INGREDIENT

Inactive Ingredients: Distilled water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Sorbic acid, Frankincense oil, Myrrh oil, Tea Tree Oil, Grapefruit seed extract

PURPOSE

Use: Temporary relief of fever.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

Warnings: FOR EXTERNAL USE ONLY.
Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APIS BELLADONNA 
apis belladonna cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-1046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	2 [hp_X]  in 1 g
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	5 [hp_X]  in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	7 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	7 [hp_X]  in 1 g
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	9 [hp_X]  in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	16 [hp_X]  in 1 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	16 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBIC ACID (UNII: X045WJ989B)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
MYRRH OIL (UNII: H74221J5J4)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-1046-5	60 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2009

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

Labeler - Uriel Pharmacy Inc. (043471163)

Establishment
Name	Address	ID/FEI	Business Operations
Uriel Pharmacy Inc.		043471163	manufacture(48951-1046)