R253

R253
SPL v1
SPL
SPL Set ID 82b1a723-63e6-41b4-9940-a984dd719c87
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Causticum (3 [hp_X]) Arnica Montana Whole (4 [hp_X]) Pulsatilla Montana Whole (6 [hp_X]) Calcium Sulfide (8 [hp_X]) Diethyl Oxalacetate (10 [hp_X]) Oxogluric Acid (12 [hp_X]) Arsenic Cation (3+) Fumaric Acid Bos Taurus Placenta Histamine Sulfur
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Causticum 3X Arnica montana 4X Pulsatilla 6X Hepar sulphuris calcareum 8X Natrum oxalaceticum 8X a-Ketoglutaricum acidum 10X Arsenicum album 10X Fumaricum acidum 10X Placenta 10X Histaminum hydrochloricum 12X Sulphur 12X


Medication Information

Description

Causticum 3X Arnica montana 4X Pulsatilla 6X Hepar sulphuris calcareum 8X Natrum oxalaceticum 8X a-Ketoglutaricum acidum 10X Arsenicum album 10X Fumaricum acidum 10X Placenta 10X Histaminum hydrochloricum 12X Sulphur 12X

Label

Est 1985

Professional Formulas

Complementary Health

Causticum 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

Consult a doctor if condition worsens or if symptoms persist. 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.

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 skin conditions such as minor pain, blistering, or redness due to sunburn, small scalds, or other minor burns.*

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

Causticum 3X

Arnica montana 4X

Pulsatilla 6X

Hepar sulphuris calcareum 8X

Natrum oxalaceticum 8X

a-Ketoglutaricum acidum 10X

Arsenicum album 10X

Fumaricum acidum 10X

Placenta 10X

Histaminum hydrochloricum 12X

Sulphur 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Causticum 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)

Consult a doctor if condition worsens or if symptoms persist. 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.

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 skin conditions such as minor pain, blistering, or redness due to sunburn, small scalds, or other minor burns.*

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)

Causticum 3X

Arnica montana 4X

Pulsatilla 6X

Hepar sulphuris calcareum 8X

Natrum oxalaceticum 8X

a-Ketoglutaricum acidum 10X

Arsenicum album 10X

Fumaricum acidum 10X

Placenta 10X

Histaminum hydrochloricum 12X

Sulphur 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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