N1

N1
SPL v1
SPL
SPL Set ID b39baa68-71bb-4e8c-9698-bbe56c36bdc4
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pleospora Herbarum (30 [hp_X]) Aspergillus Niger Var. Niger Candida Albicans Candida Torresii Candida Tropicalis Rhodotorula Rubra Geotrichum Candidum Mucor Racemosus Penicillin G Aureobasidium Pullulans Var. Pullutans Rhizopus Stolonifer
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Alternaria 30X, 60X, 100X Aspergillus niger 30X, 60X, 100X Candida albicans 30X, 60X, 100X Candida torresii 30X, 60X, 100X Candida tropicalis 30X, 60X, 100X Cryptococcus 30X, 60X, 100X Geotrichum candidum 30X, 60X, 100X Mucor racemosus 30X, 60X, 100X Penicillium notatum 30X, 60X, 100X Pullularia pullulans 30X, 60X, 100X Rhizopus nigricans 30X, 60X, 100X


Medication Information

Description

Alternaria 30X, 60X, 100X Aspergillus niger 30X, 60X, 100X Candida albicans 30X, 60X, 100X Candida torresii 30X, 60X, 100X Candida tropicalis 30X, 60X, 100X Cryptococcus 30X, 60X, 100X Geotrichum candidum 30X, 60X, 100X Mucor racemosus 30X, 60X, 100X Penicillium notatum 30X, 60X, 100X Pullularia pullulans 30X, 60X, 100X Rhizopus nigricans 30X, 60X, 100X

Label

Est 1985

Professional Formulas

Complementary Health

Mycosis Nosode

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

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, 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 to 15 drops once weekly or monthly. If mild symptoms are present, 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 runny nose, sneezing, itching of the nose or throat, itchy or watery eyes, headache, chills, or irritated, red, or itchy skin.*

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

Alternaria 30X, 60X, 100X

Aspergillus niger 30X, 60X, 100X

Candida albicans 30X, 60X, 100X

Candida torresii 30X, 60X, 100X

Candida tropicalis 30X, 60X, 100X

Cryptococcus 30X, 60X, 100X

Geotrichum candidum 30X, 60X, 100X

Mucor racemosus 30X, 60X, 100X

Penicillium notatum 30X, 60X, 100X

Pullularia pullulans 30X, 60X, 100X

Rhizopus nigricans 30X, 60X, 100X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Mycosis Nosode

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)

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, 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 to 15 drops once weekly or monthly. If mild symptoms are present, 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 runny nose, sneezing, itching of the nose or throat, itchy or watery eyes, headache, chills, or irritated, red, or itchy skin.*

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)

Alternaria 30X, 60X, 100X

Aspergillus niger 30X, 60X, 100X

Candida albicans 30X, 60X, 100X

Candida torresii 30X, 60X, 100X

Candida tropicalis 30X, 60X, 100X

Cryptococcus 30X, 60X, 100X

Geotrichum candidum 30X, 60X, 100X

Mucor racemosus 30X, 60X, 100X

Penicillium notatum 30X, 60X, 100X

Pullularia pullulans 30X, 60X, 100X

Rhizopus nigricans 30X, 60X, 100X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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