Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 6c346a26-26a2-4be0-b8a3-bbb5709bcf3d
Route
ORAL
Published
Effective Date 2024-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Equisetum Hyemale (3 [hp_X]) Comfrey Root (6 [hp_X]) Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Fluoride Ion (15 [hp_X]) Calcium Cation Sus Scrofa Bone Marrow Cod Liver Oil Silicon Dioxide Hekla Lava
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-05-21

Description

(in each drop):  12.49% of Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 15X, Medulla Ossis Suis 12X, Oleum Morrhuae 12X, Silicea 12X, Symphytum Officinale 6X; 0.10% of Equisetum Hyemale.

Purpose

May temporarily relieve pain in lower back with burning, soreness in the sacroiliac area, and pain in the joints and bones.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

May temporarily relieve pain in lower back with burning, soreness in the sacroiliac area, and pain in the joints and bones.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop):  12.49% of Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 15X, Medulla Ossis Suis 12X, Oleum Morrhuae 12X, Silicea 12X, Symphytum Officinale 6X; 0.10% of Equisetum Hyemale.

Purpose:

May temporarily relieve pain in lower back with burning, soreness in the sacroiliac area, and pain in the joints and bones.**

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

Warnings:

If pregnant or breastfeeding, ask a health professional before use.

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

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

Store in a cool, dry place.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve pain in lower back with burning, soreness in the sacroiliac area, and pain in the joints and bones.**

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

Active Ingredients:

(in each drop): 12.49% of Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 15X, Medulla Ossis Suis 12X, Oleum Morrhuae 12X, Silicea 12X, Symphytum Officinale 6X; 0.10% of Equisetum Hyemale.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OSTEOPAR

1 fl. oz. (30 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:)

May temporarily relieve pain in lower back with burning, soreness in the sacroiliac area, and pain in the joints and bones.**

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

Warnings: (WARNINGS:)

If pregnant or breastfeeding, ask a health professional before use.

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

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

Store in a cool, dry place.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

Directions: (DIRECTIONS:)

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve pain in lower back with burning, soreness in the sacroiliac area, and pain in the joints and bones.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 12.49% of Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 15X, Medulla Ossis Suis 12X, Oleum Morrhuae 12X, Silicea 12X, Symphytum Officinale 6X; 0.10% of Equisetum Hyemale.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OSTEOPAR

1 fl. oz. (30 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

All Sections (JSON)