N12

N12
SPL v1
SPL
SPL Set ID a0e0fe46-5f78-4ac4-bcbe-08ee82a98d38
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Human Herpesvirus 1 (30 [hp_X]) Human Herpesvirus 6 Human Herpesvirus 7 Human Herpesvirus 8 Recombinant Varicella Zoster Virus Glycoprotein E Antigen
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Herpes simplex 1 and 2 30X, 60X, 100X Herpes type 6 30X, 60X, 100X Herpes type 7 30X, 60X, 100X Herpes type 8 30X, 60X, 100X Herpes zoster 30X, 60X, 100X


Medication Information

Description

Herpes simplex 1 and 2 30X, 60X, 100X Herpes type 6 30X, 60X, 100X Herpes type 7 30X, 60X, 100X Herpes type 8 30X, 60X, 100X Herpes zoster 30X, 60X, 100X

Label

Est 1985

Professional Formulas

Complementary Health

Herpetic 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

Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if symptoms persist or are accompanied by a fever. 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 mild skin rash, cold sores, irritability, mild ear pain, vomiting, or diarrhea.*

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

Herpes simplex 1 and 2 30X, 60X, 100X

Herpes type 6 30X, 60X, 100X

Herpes type 7 30X, 60X, 100X

Herpes type 8 30X, 60X, 100X

Herpes zoster 30X, 60X, 100X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Herpetic 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)

Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if symptoms persist or are accompanied by a fever. 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 mild skin rash, cold sores, irritability, mild ear pain, vomiting, or diarrhea.*

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)

Herpes simplex 1 and 2 30X, 60X, 100X

Herpes type 6 30X, 60X, 100X

Herpes type 7 30X, 60X, 100X

Herpes type 8 30X, 60X, 100X

Herpes zoster 30X, 60X, 100X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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