X38

X38
SPL v1
SPL
SPL Set ID b308ca7b-0932-49e2-bdfe-e26ab0bdb2c2
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]) Taraxacum Officinale (6 [hp_X]) Trifolium Pratense Flower (30 [hp_X]) Chlorophyll (12 [hp_X]) Anthracene Benzene Xylene (mixed Isomers) Propylene Glycol Liquid Petroleum Polycyclic Aromatic Hydrocarbons
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Arctium lappa 3X Taraxacum officinale 3X Trifolium pratense 3X Chlorophyllum 6X Anthracene 30X Benzene 30X Xylene 30X Dispersant isode combination 12X, 30X, 60X, 100X Gulf water 12X, 30X, 60X, 100X Petroleum 12X, 30X, 60X, 100X Hydrocarbons (various) 30X, 60X, 100X


Medication Information

Description

Arctium lappa 3X Taraxacum officinale 3X Trifolium pratense 3X Chlorophyllum 6X Anthracene 30X Benzene 30X Xylene 30X Dispersant isode combination 12X, 30X, 60X, 100X Gulf water 12X, 30X, 60X, 100X Petroleum 12X, 30X, 60X, 100X Hydrocarbons (various) 30X, 60X, 100X

Label

Est 1985

Professional Formulas

Complementary Health

Gulf Detox

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

Consult a doctor if condition worsens or 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 cough, wheezing, eye, nose, or throat irritation, watery or itchy eyes, occasional headache, nausea, sore throat, fatigue, or tiredness due to sensitivity to or exposure to contaminants found in oil spills.*

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

Taraxacum officinale 3X

Trifolium pratense 3X

Chlorophyllum 6X

Anthracene 30X

Benzene 30X

Xylene 30X

Dispersant isode combination 12X, 30X, 60X, 100X

Gulf water 12X, 30X, 60X, 100X

Petroleum 12X, 30X, 60X, 100X

Hydrocarbons (various) 30X, 60X, 100X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Gulf Detox

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)

Consult a doctor if condition worsens or 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 cough, wheezing, eye, nose, or throat irritation, watery or itchy eyes, occasional headache, nausea, sore throat, fatigue, or tiredness due to sensitivity to or exposure to contaminants found in oil spills.*

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

Taraxacum officinale 3X

Trifolium pratense 3X

Chlorophyllum 6X

Anthracene 30X

Benzene 30X

Xylene 30X

Dispersant isode combination 12X, 30X, 60X, 100X

Gulf water 12X, 30X, 60X, 100X

Petroleum 12X, 30X, 60X, 100X

Hydrocarbons (various) 30X, 60X, 100X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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