SPL v2
SPL
SPL Set ID 820c87ee-348f-4ccb-adb7-b4486f9a8d3f
Route
TOPICAL
Published
Effective Date 2015-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X])
Inactive Ingredients
Aloe Vera Leaf Caprylyl Glycol Hexylene Glycol Hydroxyethyl Cellulose (100 Mpa.s At 2%) Phenoxyethanol Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-06-23

Description

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


Medication Information

Warnings and Precautions

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.

Indications and 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 and 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).

Description

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

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 55105-1

Pain, Bruises, Inuries, Muscle Aches

Section 55106-9

Active Ingredients                                       Purpose

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


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

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 and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain, Bruises, Inuries, Muscle Aches

Section 55106-9 (55106-9)

Active Ingredients                                       Purpose

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)