C1

C1
SPL v1
SPL
SPL Set ID 340fc7dc-2aa4-411f-842b-4ce704671722
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arctium Lappa Root Oil (3 [hp_X]) Berberis Aquifolium Root Bark (4 [hp_X]) Centella Asiatica Leaf (6 [hp_X]) Rhododendron Tomentosum Leafy Twig (8 [hp_X]) Strychnos Nux-vomica Seed (12 [hp_X]) Sanguinaria Canadensis Root (15 [hp_X]) Silicon Dioxide Sulfur Antimony Trisulfide Bromide Ion Chloride Ion Carbo Animalis
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Arctium lappa 3X Berberis aquifolium 3X Hydrocotyle asiatica 3X Ledum palustre 4X Nux vomica 6X Sanguinaria canadensis 6X Silicea 6X Sulphur 6X Antimonium crudum 8X Kali bromatum 12X Natrum muriaticum 12X Carbo animalis 15X


Medication Information

Description

Arctium lappa 3X Berberis aquifolium 3X Hydrocotyle asiatica 3X Ledum palustre 4X Nux vomica 6X Sanguinaria canadensis 6X Silicea 6X Sulphur 6X Antimonium crudum 8X Kali bromatum 12X Natrum muriaticum 12X Carbo animalis 15X

Label

Est 1985

Professional Formulas

Complementary Health

Acne Drops

Homeopathic Remedy

2 FL. OZ. (59 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

If symptoms do not improve, are severe, or are accompanied by scarring, 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.

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 acne-like conditions, blackheads, or pimples.*

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

Arctium lappa 3X

Berberis aquifolium 3X

Hydrocotyle asiatica 3X

Ledum palustre 4X

Nux vomica 6X

Sanguinaria canadensis 6X

Silicea 6X

Sulphur 6X

Antimonium crudum 8X

Kali bromatum 12X

Natrum muriaticum 12X

Carbo animalis 15X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Acne Drops

Homeopathic Remedy

2 FL. OZ. (59 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)

If symptoms do not improve, are severe, or are accompanied by scarring, 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.

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 acne-like conditions, blackheads, or pimples.*

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)

Arctium lappa 3X

Berberis aquifolium 3X

Hydrocotyle asiatica 3X

Ledum palustre 4X

Nux vomica 6X

Sanguinaria canadensis 6X

Silicea 6X

Sulphur 6X

Antimonium crudum 8X

Kali bromatum 12X

Natrum muriaticum 12X

Carbo animalis 15X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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