Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID d008a091-b7c6-41f1-a1cf-f8224ebe55e5
Route
ORAL
Published
Effective Date 2023-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Egg Shell Membrane (6 [hp_X]) Whey (30 [hp_X]) Oyster Shell Calcium Carbonate, Crude (12 [hp_C]) Lycopodium Clavatum Spore Sulfur Arsenic Cation (3+) Fagopyrum Esculentum Graphite Centella Asiatica Chloride Ion
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-03-15 Until 2028-04-18

Description

(in each drop) Arsenicum Album 12C 12.48%, Calcarea Carbonica 30X 12.48%, Fagopyrum Esculentum 12C 12.48%, Graphites 12C 12.48%, Hydrocotyle Asiatica 12C 12.48%, Lycopodium Clavatum 30X 12.48%, Natrum Muriaticum 12C 12.48%, Sulphur 30X 12.48%, Eggshell Membrane 6X 0.10%, Whey Protein 6X 0.10%.

Purpose

Arsenicum Album – burning pains**, Calcarea Carbonica – chilliness**, Fagopyrum Esculentum – itching**, Graphites – weight gain**, Hydrocotyle Asiatica – dry skin**, Lycopodium Clavatum – anxiety**, Natrum Muriaticum – sadness**, Sulphur – eczema**, Eggshell Membrane – joint pain**, Whey Protein – skin eruptions**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Arsenicum Album – burning pains**, Calcarea Carbonica – chilliness**, Fagopyrum Esculentum – itching**, Graphites – weight gain**, Hydrocotyle Asiatica – dry skin**, Lycopodium Clavatum – anxiety**, Natrum Muriaticum – sadness**, Sulphur – eczema**, Eggshell Membrane – joint pain**, Whey Protein – skin eruptions**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop) Arsenicum Album 12C 12.48%, Calcarea Carbonica 30X 12.48%, Fagopyrum Esculentum 12C 12.48%, Graphites 12C 12.48%, Hydrocotyle Asiatica 12C 12.48%, Lycopodium Clavatum 30X 12.48%, Natrum Muriaticum 12C 12.48%, Sulphur 30X 12.48%, Eggshell Membrane 6X 0.10%, Whey Protein 6X 0.10%.

Purpose:

Arsenicum Album – burning pains**, Calcarea Carbonica – chilliness**, Fagopyrum Esculentum – itching**, Graphites – weight gain**, Hydrocotyle Asiatica – dry skin**, Lycopodium Clavatum – anxiety**, Natrum Muriaticum – sadness**, Sulphur – eczema**, Eggshell Membrane – joint pain**, Whey Protein – skin eruptions**.

**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 7 days.

If pregnant or breast-feeding, 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.

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

Indications:

May temporarily relieve: • itching of the skin • eruption on the scalp and bends of joints with itching • skin that is dry, scaly • general exhaustion.**

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

Active Ingredients:

(in each drop) Arsenicum Album 12C 12.48%, Calcarea Carbonica 30X 12.48%, Fagopyrum Esculentum 12C 12.48%, Graphites 12C 12.48%, Hydrocotyle Asiatica 12C 12.48%, Lycopodium Clavatum 30X 12.48%, Natrum Muriaticum 12C 12.48%, Sulphur 30X 12.48%, Eggshell Membrane 6X 0.10%, Whey Protein 6X 0.10%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

PSORA

MIASM

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.


Structured Label Content

Purpose: (PURPOSE:)

Arsenicum Album – burning pains**, Calcarea Carbonica – chilliness**, Fagopyrum Esculentum – itching**, Graphites – weight gain**, Hydrocotyle Asiatica – dry skin**, Lycopodium Clavatum – anxiety**, Natrum Muriaticum – sadness**, Sulphur – eczema**, Eggshell Membrane – joint pain**, Whey Protein – skin eruptions**.

**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 7 days.

If pregnant or breast-feeding, 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.

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

Indications: (INDICATIONS:)

May temporarily relieve: • itching of the skin • eruption on the scalp and bends of joints with itching • skin that is dry, scaly • general exhaustion.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) Arsenicum Album 12C 12.48%, Calcarea Carbonica 30X 12.48%, Fagopyrum Esculentum 12C 12.48%, Graphites 12C 12.48%, Hydrocotyle Asiatica 12C 12.48%, Lycopodium Clavatum 30X 12.48%, Natrum Muriaticum 12C 12.48%, Sulphur 30X 12.48%, Eggshell Membrane 6X 0.10%, Whey Protein 6X 0.10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

PSORA

MIASM

1 fl. oz. (30 ml)

Keep Out of Reach of Children: (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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