Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 62ce13b1-ca8d-4d6b-932d-db13a816bc37
Route
TOPICAL
Published
Effective Date 2022-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X]) Hypericum Perforatum (12 [hp_X]) Arsenic Cation (3+) Atropa Belladonna Lytta Vesicatoria Causticum Dichromate Ion Picric Acid Urtica Urens
Inactive Ingredients
Glycerin Water Aloe Vera Leaf Benzyl Alcohol Ethylhexylglycerin Tocopherol Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Edetate Disodium Anhydrous Sodium Hydroxide Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-11-18

Description

(in each drop): 8.31% of Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Hypericum Perforatum 30X, Kali Bichromicum 12X, Picricum Acidum 12X, Urtica Urens 12X; 1.75% of Calendula Officinalis 1X, Hypericum Perforatum 1X.

Purpose

May temporarily relieve itching, pain, and swelling associated with minor burns.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

May temporarily relieve itching, pain, and swelling associated with minor burns.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): 8.31% of Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Hypericum Perforatum 30X, Kali Bichromicum 12X, Picricum Acidum 12X, Urtica Urens 12X; 1.75% of Calendula Officinalis 1X, Hypericum Perforatum 1X.

Uses:

May temporarily relieve itching, pain, and swelling associated with minor burns.**

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

Purpose:

May temporarily relieve itching, pain, and swelling associated with minor burns.**

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

Warnings:

For external use only.

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

Directions:

Spray on affected area as needed. Shake well before using.

Active Ingredients:

(in each drop): 8.31% of Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Hypericum Perforatum 30X, Kali Bichromicum 12X, Picricum Acidum 12X, Urtica Urens 12X; 1.75% of Calendula Officinalis 1X, Hypericum Perforatum 1X.

Inactive Ingredients:

Water, Ethanol, Glycerin, Aloe vers leaf juice extract, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 alkyl acrylate crosspolymer, Disodium EDTA, Sodium hydroxide. 

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

BURN AIDE

SPRAY

6 fl. OZ. (180 ml)

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

Uses: (USES:)

May temporarily relieve itching, pain, and swelling associated with minor burns.**

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

Purpose: (PURPOSE:)

May temporarily relieve itching, pain, and swelling associated with minor burns.**

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

Warnings: (WARNINGS:)

For external use only.

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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

Directions: (DIRECTIONS:)

Spray on affected area as needed. Shake well before using.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 8.31% of Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Hypericum Perforatum 30X, Kali Bichromicum 12X, Picricum Acidum 12X, Urtica Urens 12X; 1.75% of Calendula Officinalis 1X, Hypericum Perforatum 1X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water, Ethanol, Glycerin, Aloe vers leaf juice extract, 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

BURN AIDE

SPRAY

6 fl. OZ. (180 ml)

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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