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

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.


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

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