Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 43d65eee-f4c3-4a6a-a3bb-cfa6d672bc47
Route
ORAL
Published
Effective Date 2018-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (6 [hp_X])
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-10-01

Description

(in each drop):  24.98% of Hydrocortisone 12X, 30X, 12C, 30C; 0.10 % of Hydrocortisone 6X.


Medication Information

Description

(in each drop):  24.98% of Hydrocortisone 12X, 30X, 12C, 30C; 0.10 % of Hydrocortisone 6X.

Warnings:

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, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve symptoms associated with reactions to cortisol.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Active Ingredient:

(in each drop): 24.98% of Hydrocortisone 12X, 30X, 12C, 30C; 0.10 % of Hydrocortisone 6X.

Inactive Ingredients:

Demineralized water, 20% Ethanol

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CORTISOL

PHENOLIC

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

Warnings: (WARNINGS:)

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, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve symptoms associated with reactions to cortisol.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Active Ingredient: (ACTIVE INGREDIENT:)

(in each drop): 24.98% of Hydrocortisone 12X, 30X, 12C, 30C; 0.10 % of Hydrocortisone 6X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CORTISOL

PHENOLIC

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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