Drug Facts:

Drug Facts:
SPL v7
SPL
SPL Set ID 8e9cd014-d0fa-4e8e-bd02-5b7bf27673ff
Route
TOPICAL
Published
Effective Date 2022-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Apis Mellifera (12 [hp_X]) Atropa Belladonna (15 [hp_X]) Oyster Shell Calcium Carbonate, Crude Daphne Mezereum Bark Toxicodendron Pubescens Leaf Astacus Astacus Gelsemium Sempervirens Root
Inactive Ingredients
Water Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Benzyl Alcohol Ethylhexylglycerin Tocopherol Sodium Hydroxide Aloe Vera Leaf Edetate Disodium

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-04-02

Description

(in gel):  4.29% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X,  Mezereum 12X, Rhus Tox 12X.


Medication Information

Description

(in gel):  4.29% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X,  Mezereum 12X, Rhus Tox 12X.

Warnings:

For external use only. If an adverse reaction occurs, discontinue use.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, 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. Do not expose product to extreme temperatures.

Questions:

Dist. by Energique, Inc., 201 Apple Blvd.

Woodbine, IA 51579       800.869.8078

Directions:

Apply topically to affected area 4 to 6 times daily.

Indications:

May temporarily relieve itching, redness, and skin irritation due to rashes, eczema, insect bites, and other skin eruptions**

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

Active Ingredients:

(in gel): 4.29% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, 

Mezereum 12X, Rhus Tox 12X.

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CORT SYM GEL

ANTI-ITCH

Net wt. 2 oz. (57 g)

Keep Out of Reach of Children:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings: (WARNINGS:)

For external use only. If an adverse reaction occurs, discontinue use.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, 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. Do not expose product to extreme temperatures.

Questions: (QUESTIONS:)

Dist. by Energique, Inc., 201 Apple Blvd.

Woodbine, IA 51579       800.869.8078

Directions: (DIRECTIONS:)

Apply topically to affected area 4 to 6 times daily.

Indications: (INDICATIONS:)

May temporarily relieve itching, redness, and skin irritation due to rashes, eczema, insect bites, and other skin eruptions**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in gel): 4.29% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, 

Mezereum 12X, Rhus Tox 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CORT SYM GEL

ANTI-ITCH

Net wt. 2 oz. (57 g)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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