Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 6e48c2a9-f08a-418f-9b25-03a2010c340f
Route
ORAL
Published
Effective Date 2024-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Astragalus Propinquus Root (3 [hp_X]) Echinacea Angustifolia (6 [hp_X]) Hypericum Perforatum (12 [hp_X]) Goldenseal Solanum Dulcamara Top Gelsemium Sempervirens Root Nitric Acid Ranunculus Bulbosus Thuja Occidentalis Leafy Twig
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-05-24

Description

(in each drop): Dulcamara 12X 16.62%, Gelsemium Sempervirens 12X 16.62%, Hydrastis Canadensis 6X 16.62%, Nitricum Acidum 12X 16.62%, Ranunculus Bulbosus 12X 16.62%, Thuja Occidentalis 12X 16.62%, Astragalus Membranaceus 3X 0.10%, Echinacea (Angustifolia) 3X 0.10%, Hypericum Perforatum 3X 0.10%.

Purpose

Dulcamara - itching,** Gelsemium Sempervirens - redness,** Hydrastis Canadensis – burning pain,** Nitricum Acidum – stitching pain,** Ranunculus Bulbosus – stinging pain,** Thuja Occidentalis – tingling,** Astragalus Membranaceus - fatigue,** Echinacea - rash,** Hypericum Perforatum – sensitive skin** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Dulcamara - itching,** Gelsemium Sempervirens - redness,** Hydrastis Canadensis – burning pain,** Nitricum Acidum – stitching pain,** Ranunculus Bulbosus – stinging pain,** Thuja Occidentalis – tingling,** Astragalus Membranaceus - fatigue,** Echinacea - rash,** Hypericum Perforatum – sensitive skin** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): Dulcamara 12X 16.62%, Gelsemium Sempervirens 12X 16.62%, Hydrastis Canadensis 6X 16.62%, Nitricum Acidum 12X 16.62%, Ranunculus Bulbosus 12X 16.62%, Thuja Occidentalis 12X 16.62%, Astragalus Membranaceus 3X 0.10%, Echinacea (Angustifolia) 3X 0.10%, Hypericum Perforatum 3X 0.10%.

Uses:

May temporarily relieve symptoms associated with infections:

• aches • pains • febrile conditions • painful skin lesions**

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

Purpose:

Dulcamara - itching,** Gelsemium Sempervirens - redness,** Hydrastis Canadensis – burning pain,** Nitricum Acidum – stitching pain,** Ranunculus Bulbosus – stinging pain,** Thuja Occidentalis – tingling,** Astragalus Membranaceus - fatigue,** Echinacea - rash,** Hypericum Perforatum – sensitive skin**

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

Warnings:

Stop use and ask a doctor if symptoms persist for more than 3 days.

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 UE 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.

• Consult a physician for use in children under 12 years of age.

Active Ingredients:

(in each drop): Dulcamara 12X 16.62%, Gelsemium Sempervirens 12X 16.62%, Hydrastis Canadensis 6X 16.62%, Nitricum Acidum 12X 16.62%, Ranunculus Bulbosus 12X 16.62%, Thuja Occidentalis 12X 16.62%, Astragalus Membranaceus 3X 0.10%, Echinacea (Angustifolia) 3X 0.10%, Hypericum Perforatum 3X 0.10%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Lable Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DERMATOME STAT

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

Uses: (USES:)

May temporarily relieve symptoms associated with infections:

• aches • pains • febrile conditions • painful skin lesions**

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

Purpose: (PURPOSE:)

Dulcamara - itching,** Gelsemium Sempervirens - redness,** Hydrastis Canadensis – burning pain,** Nitricum Acidum – stitching pain,** Ranunculus Bulbosus – stinging pain,** Thuja Occidentalis – tingling,** Astragalus Membranaceus - fatigue,** Echinacea - rash,** Hypericum Perforatum – sensitive skin**

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

Warnings: (WARNINGS:)

Stop use and ask a doctor if symptoms persist for more than 3 days.

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 UE 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.

• Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): Dulcamara 12X 16.62%, Gelsemium Sempervirens 12X 16.62%, Hydrastis Canadensis 6X 16.62%, Nitricum Acidum 12X 16.62%, Ranunculus Bulbosus 12X 16.62%, Thuja Occidentalis 12X 16.62%, Astragalus Membranaceus 3X 0.10%, Echinacea (Angustifolia) 3X 0.10%, Hypericum Perforatum 3X 0.10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Lable Display: (PACKAGE LABLE DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DERMATOME STAT

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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