ARNICA NETTLE BURN AND BITE gel

Arnica Nettle Burn and Bite by

Drug Labeling and Warnings

Arnica Nettle Burn and Bite 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 gel to skin as soon as possible. Reapply several times daily. Under age 2: Consult a doctor.

ACTIVE INGREDIENT

Active Ingredients: 100 gm contains: 4.5 gm Urtica urens ex herba 1X, 1.5 gm Arnica e flor. 1X; Calendula ex herba 2X, Resina laricis 2X, Thuja e summ. 2X, Symphytum ex herba 2X, Cantharis ex animale 7X, Colloidal silver 8X

INACTIVE INGREDIENT

Inactive Ingredients: Distilled water, Glycerin, Organic cane alcohol, Sodium alginate, Aloe vera, Cajeput oil, Potassium sorbate, Rosemary oil, Tea tree oil, Thyme oil, Grapefruit seed extract

PURPOSE

Uses: Temporary relief of burns, sunburn, insect bites, bee stings and rashes.

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. FOR BURNS, SEEK MEDICAL ATTENTION IF NEEDED.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA NETTLE BURN AND BITE 
arnica nettle burn and bite gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-1148
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	2 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	2 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	2 [hp_X]  in 1 g
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N)	THUJA OCCIDENTALIS WHOLE	2 [hp_X]  in 1 g
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	2 [hp_X]  in 1 g
LARIX DECIDUA RESIN (UNII: AD8LJ73GQF) (LARIX DECIDUA RESIN - UNII:AD8LJ73GQF)	LARIX DECIDUA RESIN	3 [hp_X]  in 1 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	6 [hp_X]  in 1 g
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	7 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAJUPUT OIL (UNII: J3TO6BUQ37)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ROSEMARY OIL (UNII: 8LGU7VM393)
TEA TREE OIL (UNII: VIF565UC2G)
THYME OIL (UNII: 2UK410MY6B)
CITRUS PARADISI SEED (UNII: 12F08874Y7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-1148-5	60 g in 1 TUBE

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(48951-1148)