r208

r208
SPL v1
SPL
SPL Set ID 1b5fde7b-c5de-48b6-8c10-54efb54ecad3
Route
oral
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
arnica montana whole (3 [hp_X]) benzoic acid (4 [hp_X]) echinacea angustifolia whole (6 [hp_X]) mercurialis perennis whole apis mellifera baptisia tinctoria whole bryonia alba root colchicum autumnale bulb solanum dulcamara whole eucalyptus globulus leaf solanum nigrum top eupatorium perfoliatum flowering top toxicodendron pubescens leaf
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 1984-08-15

Description

Arnica montana 3X Benzoicum acidum 3X Echinacea angustifolia 3X Mercurialis perennis 3X Apis mellifica 4X Baptisia tinctoria 4X Bryonia 4X Colchicum autumnale 4X Dulcamara 4X Eucalyptus globulus 4X Solanum nigrum 4X Eupatorium perfoliatum 6X Rhus toxicodendron 6X


Medication Information

Warnings

If symptoms do not improve or are accompanied by a fever, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

40% ethanol, purified water.

Description

Arnica montana 3X Benzoicum acidum 3X Echinacea angustifolia 3X Mercurialis perennis 3X Apis mellifica 4X Baptisia tinctoria 4X Bryonia 4X Colchicum autumnale 4X Dulcamara 4X Eucalyptus globulus 4X Solanum nigrum 4X Eupatorium perfoliatum 6X Rhus toxicodendron 6X

Label

Est 1985

Professional Formulas

Complementary Health

Arnica Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Section 50565-1

Keep out of the reach of children.

Section 53414-9

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

For the temporary relief of inflammation, or minor joint pain or swelling.*

Active Ingredients

Arnica montana 3X

Benzoicum acidum 3X

Echinacea angustifolia 3X

Mercurialis perennis 3X

Apis mellifica 4X

Baptisia tinctoria 4X

Bryonia 4X

Colchicum autumnale 4X

Dulcamara 4X

Eucalyptus globulus 4X

Solanum nigrum 4X

Eupatorium perfoliatum 6X

Rhus toxicodendron 6X


Structured Label Content

Warnings (WARNINGS)

If symptoms do not improve or are accompanied by a fever, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Directions (DIRECTIONS)

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Other Information (OTHER INFORMATION)

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Arnica Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications (INDICATIONS)

For the temporary relief of inflammation, or minor joint pain or swelling.*

Active Ingredients (ACTIVE INGREDIENTS)

Arnica montana 3X

Benzoicum acidum 3X

Echinacea angustifolia 3X

Mercurialis perennis 3X

Apis mellifica 4X

Baptisia tinctoria 4X

Bryonia 4X

Colchicum autumnale 4X

Dulcamara 4X

Eucalyptus globulus 4X

Solanum nigrum 4X

Eupatorium perfoliatum 6X

Rhus toxicodendron 6X


Advanced Ingredient Data


Raw Label Data

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