N21

N21
SPL v1
SPL
SPL Set ID 548fa998-c34b-47c9-b401-c827fa2dc0c0
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Candida Albicans (12 [hp_X]) Candida Torresii (6 [hp_X]) Candida Tropicalis Pleospora Herbarum Aspergillus Niger Var. Niger 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

Candida albicans 12X Candida torresii 12X Candida tropicalis 12X and all the following at 6X, 12X: Alternaria Aspergillus niger Cryptococcus Geotrichum candidum Mucor racemosus Penicillium notatum Pullularia pullulans Rhizopus nigricans


Medication Information

Description

Candida albicans 12X Candida torresii 12X Candida tropicalis 12X and all the following at 6X, 12X: Alternaria Aspergillus niger Cryptococcus Geotrichum candidum Mucor racemosus Penicillium notatum Pullularia pullulans Rhizopus nigricans

Label

Est 1985

Professional Formulas

Complementary Health

Low 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

Candida albicans 12X

Candida torresii 12X

Candida tropicalis 12X

and all the following at 6X, 12X:

Alternaria

Aspergillus niger

Cryptococcus

Geotrichum candidum

Mucor racemosus

Penicillium notatum

Pullularia pullulans

Rhizopus nigricans

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Low 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)

Candida albicans 12X

Candida torresii 12X

Candida tropicalis 12X

and all the following at 6X, 12X:

Alternaria

Aspergillus niger

Cryptococcus

Geotrichum candidum

Mucor racemosus

Penicillium notatum

Pullularia pullulans

Rhizopus nigricans

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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