Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 69121519-3b95-4811-87f1-3f8a0d532f69
Route
ORAL
Published
Effective Date 2024-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Thuja Occidentalis Leafy Twig (4 [hp_X]) Nitric Acid (6 [hp_X]) Causticum (18 [hp_X]) Juniperus Sabina Leafy Twig (20 [hp_X]) Antimony Cation (3+) (30 [hp_X]) Human Papillomavirus (20 [hp_C]) Alcohol, X-ray Exposed (1000 Rad) Human Adenovirus E Serotype 4 Strain Cl-68578
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-07-25

Description

Thuja Occidentalis 4X, Nitricum Acidum 6X, 8X, Causticum 6X, 12X, 30X, Sabina 6X, 12X, 30X, Antimonium Sulphuratum Rubrum 18X, Human Papilloma Nosode 20X, 60X, 100X, X-Ray 30X, 60X, Adenoviren Nosode 20C, 60C, 100C.

Purpose

Aids in the temporary relief of itching of the groin area.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in the temporary relief of itching of the groin area.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Thuja Occidentalis 4X, Nitricum Acidum 6X, 8X, Causticum 6X, 12X, 30X, Sabina 6X, 12X, 30X, Antimonium Sulphuratum Rubrum 18X, Human Papilloma Nosode 20X, 60X, 100X, X-Ray 30X, 60X, Adenoviren Nosode 20C, 60C, 100C.

Purpose:

Aids in the temporary relief of itching of the groin area.†

†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: 3 to 5 sprays three times daily. Also spray directly on affected area 3 times daily and let air dry. 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 the temporary relief of itching of the groin area.†

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

Active Ingredients:

Thuja Occidentalis 4X, Nitricum Acidum 6X, 8X, Causticum 6X, 12X, 30X, Sabina 6X, 12X, 30X, Antimonium Sulphuratum Rubrum 18X, Human Papilloma Nosode 20X, 60X, 100X, X-Ray 30X, 60X, Adenoviren Nosode 20C, 60C, 100C.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0141-1

FEMMEPAP

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 the temporary relief of itching of the groin area.†

†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: 3 to 5 sprays three times daily. Also spray directly on affected area 3 times daily and let air dry. 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 the temporary relief of itching of the groin area.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Thuja Occidentalis 4X, Nitricum Acidum 6X, 8X, Causticum 6X, 12X, 30X, Sabina 6X, 12X, 30X, Antimonium Sulphuratum Rubrum 18X, Human Papilloma Nosode 20X, 60X, 100X, X-Ray 30X, 60X, Adenoviren Nosode 20C, 60C, 100C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0141-1

FEMMEPAP

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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