R228

R228
SPL v1
SPL
SPL Set ID 20e739b4-8b7c-4dd9-876d-99156ea47209
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferula Assa-foetida Resin (8 [hp_X]) Kalmia Latifolia Leaf (10 [hp_X]) Causticum Colchicum Autumnale Bulb Iron Pseudognaphalium Obtusifolium Whole Lithium Cation Mercuric Oxide Toxicodendron Pubescens Leaf Filipendula Ulmaria Root
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Asafoetida 8X Kalmia latifolia 8X Causticum 10X Colchicum autumnale 10X Ferrum metallicum 10X Gnaphalium polycephalum 10X Lithium benzoicum 10X Mercurius praecipitatus ruber 10X Rhus toxicodendron 10X Spiraea ulmaria 10X


Medication Information

Description

Asafoetida 8X Kalmia latifolia 8X Causticum 10X Colchicum autumnale 10X Ferrum metallicum 10X Gnaphalium polycephalum 10X Lithium benzoicum 10X Mercurius praecipitatus ruber 10X Rhus toxicodendron 10X Spiraea ulmaria 10X

Label

Est 1985

Professional Formulas

Complementary Health

Kalmia 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.

Warnings

In case of overdose, get medical help or contact a poison control center right away.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

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.

Indications

For the temporary relief of minor pain, stiffness, or inflammation of joints or connective tissue.*

Other Information

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

Active Ingredients

Asafoetida 8X

Kalmia latifolia 8X

Causticum 10X

Colchicum autumnale 10X

Ferrum metallicum 10X

Gnaphalium polycephalum 10X

Lithium benzoicum 10X

Mercurius praecipitatus ruber 10X

Rhus toxicodendron 10X

Spiraea ulmaria 10X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Kalmia 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.

Warnings (WARNINGS)

In case of overdose, get medical help or contact a poison control center right away.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

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.

Indications (INDICATIONS)

For the temporary relief of minor pain, stiffness, or inflammation of joints or connective tissue.*

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.

Active Ingredients (ACTIVE INGREDIENTS)

Asafoetida 8X

Kalmia latifolia 8X

Causticum 10X

Colchicum autumnale 10X

Ferrum metallicum 10X

Gnaphalium polycephalum 10X

Lithium benzoicum 10X

Mercurius praecipitatus ruber 10X

Rhus toxicodendron 10X

Spiraea ulmaria 10X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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