N-25

N-25
SPL v4
SPL
SPL Set ID db4f1434-c26b-4526-95d1-00099bf77839
Route
SUBLINGUAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Serenoa Repens Whole (2 [hp_X]) Agathosma Crenulata Whole (3 [hp_X]) Chimaphila Umbellata (6 [hp_X]) Elymus Repens Whole (200 [hp_X]) Selenium Bos Taurus Prostate Gland
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1990-01-01

Description

NDC 58264-0223-1


Medication Information

Description

NDC 58264-0223-1

Active

Sabal serrulata 2x, Barosma crenata 2x, Chimaphila umbellata 3x, Triticum repens 3x, Selenium metallicum 6x, Prostate 6/12/30/60/200x

Section 42229-5

NDC 58264-0223-1

Section 50565-1
  • Keep this and all medication out of the reach of children.
Section 50567-7
  • Use only if cap seal is unbroken.
Section 53414-9
  • If pregnant or breastfeeding, ask a healthcare professional before use.
Section 55105-1

Support for the Prostate frequent and scanty urination in men.

Inactive

20% alcohol in purified water.

Suggested Dosage

One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

Principal Display Panel 1 Fl. Oz. Bottle Label

DYNAMIC



NUTRITIONAL




ASSOCIATES, INC.

N-25



PROSTATE ENERGIZER

HOMEOPATHIC ENDOCRINE

1 FL. OZ.


Structured Label Content

Active (ACTIVE)

Sabal serrulata 2x, Barosma crenata 2x, Chimaphila umbellata 3x, Triticum repens 3x, Selenium metallicum 6x, Prostate 6/12/30/60/200x

Section 42229-5 (42229-5)

NDC 58264-0223-1

Section 50565-1 (50565-1)
  • Keep this and all medication out of the reach of children.
Section 50567-7 (50567-7)
  • Use only if cap seal is unbroken.
Section 53414-9 (53414-9)
  • If pregnant or breastfeeding, ask a healthcare professional before use.
Section 55105-1 (55105-1)

Support for the Prostate frequent and scanty urination in men.

Inactive (INACTIVE)

20% alcohol in purified water.

Suggested Dosage (SUGGESTED DOSAGE)

One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

Principal Display Panel 1 Fl. Oz. Bottle Label (PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label)

DYNAMIC



NUTRITIONAL




ASSOCIATES, INC.

N-25



PROSTATE ENERGIZER

HOMEOPATHIC ENDOCRINE

1 FL. OZ.


Advanced Ingredient Data


Raw Label Data

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