c52

c52
SPL v1
SPL
SPL Set ID 8f6985b4-a450-45e1-9393-3d6f2f248e18
Route
oral
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pygeum (2 [hp_X]) saw palmetto (3 [hp_X]) bee pollen (6 [hp_X]) zinc (12 [hp_X]) bos taurus prostate gland (30 [hp_X]) pulsatilla montana whole bovine tuberculin
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 1984-08-15

Description

Pygeum africanum 2X Sabal serrulata 2X Bee pollen 3X Zincum metallicum 3X Prostate 6X Pulsatilla 12X Tuberculinum 30X, 100X


Medication Information

Warnings

Consult a doctor if condition worsens or if 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.

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. Not intended for use in infants.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

20% ethanol, purified water.

Description

Pygeum africanum 2X Sabal serrulata 2X Bee pollen 3X Zincum metallicum 3X Prostate 6X Pulsatilla 12X Tuberculinum 30X, 100X

Label

Est 1985

Professional Formulas

Complementary Health

Prostate 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.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

For the temporary relief of difficult urination, excessive or frequent urge to urinate, or mild discomfort in the groin or genitals.*

Active Ingredients

Pygeum africanum 2X

Sabal serrulata 2X

Bee pollen 3X

Zincum metallicum 3X

Prostate 6X

Pulsatilla 12X

Tuberculinum 30X, 100X


Structured Label Content

Warnings (WARNINGS)

Consult a doctor if condition worsens or if 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.

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. Not intended for use in infants.

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.

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Prostate 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.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications (INDICATIONS)

For the temporary relief of difficult urination, excessive or frequent urge to urinate, or mild discomfort in the groin or genitals.*

Active Ingredients (ACTIVE INGREDIENTS)

Pygeum africanum 2X

Sabal serrulata 2X

Bee pollen 3X

Zincum metallicum 3X

Prostate 6X

Pulsatilla 12X

Tuberculinum 30X, 100X


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)