GERMA ARNICA RELIEF- arnica montana gel

Germa Arnica Relief by

Drug Labeling and Warnings

Germa Arnica Relief by is a Homeopathic medication manufactured, distributed, or labeled by Caribe Natural LLC, Homeocare Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                       Purpose

Arnica Montana 1X HPUS (4%)                    Pain, Bruises, Injuries, Muscle Aches

PURPOSE

Pain, Bruises, Inuries, Muscle Aches

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Germa Arnica Relief Gel

Homeopathic Medicine

Bruising & Swelling / Moreton e Hinchazon

Aches & Pains / Dolores y Molestia Muscular

Joints Pain / Dolores de Articulacion

Back Ache / Dolores de Espalda

Stiffness / Rigidez

Natural Pain Relief

DOSAGE & ADMINISTRATION

Directions:

For External Use Only. Apply generously to affected area, 2 to 3 times daily or as needed. Rub gently until complete absorption. Safe for children over 2 years old (under 2 years ask a Doctor).

WARNINGS

Warnings:

For External Use Only. Ask a Doctor before use if pregnant, or breast-feeding. When using this product: Do not get into eyes and do not apply on open skin. Stop use and ask a Doctor if: Condition worsens, symptoms last more than 7 days, or you are allergic to any of the ingredients.

INACTIVE INGREDIENT

Inactive Ingredients: aloe vera, caprylyl glycol, hexylene glycol, hydroxyethylcellulose, phenoxyethanol, potassium sorbate, purified water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERMA ARNICA RELIEF 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59561-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59561-100-02	57 g in 1 PACKAGE; Type 0: Not a Combination Product

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

Labeler - Caribe Natural LLC (624210480)

Establishment
Name	Address	ID/FEI	Business Operations
Homeocare Laboratories Inc		088248828	manufacture(59561-100)