Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 69325b08-3165-4c1e-a095-386fe8c618ec
Route
ORAL
Published
Effective Date 2023-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Saw Palmetto (4 [hp_X]) Chimaphila Umbellata (6 [hp_X]) Sus Scrofa Prostate (9 [hp_X]) Zinc (12 [hp_X]) Pulsatilla Pratensis Whole
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-10-06

Description

Sabal Serrulata 4X, Chimaphila Umbellata 6X, Prostate 6X, Zincum Metallicum 9X, Pulsatilla 12X.

Purpose

Aids in providing support for the prostate.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in providing support for the prostate.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Sabal Serrulata 4X, Chimaphila Umbellata 6X, Prostate 6X, Zincum Metallicum 9X, Pulsatilla 12X.

Purpose:

Aids in providing support for the prostate.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications

Aids in providing support for the prostate.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

Sabal Serrulata 4X, Chimaphila Umbellata 6X, Prostate 6X, Zincum Metallicum 9X, Pulsatilla 12X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0115-1

PROSTATE

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

Aids in providing support for the prostate.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (DIRECTIONS:)

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

Aids in providing support for the prostate.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

Sabal Serrulata 4X, Chimaphila Umbellata 6X, Prostate 6X, Zincum Metallicum 9X, Pulsatilla 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0115-1

PROSTATE

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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