Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 8bd9b9da-570a-4875-a5de-963155f0f837
Route
ORAL
Published
Effective Date 2023-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (8 [hp_X]) Euphrasia Stricta (12 [hp_X]) Iodide Ion Naphthalene Schoenocaulon Officinale Seed Urtica Urens Wyethia Helenioides Root Histamine
Inactive Ingredients
Water Glycerin Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-07-12

Description

(in each drop) Allium Cepa 8X 12.50%, Euphrasia Officinalis 8X 12.50%, Kali Iodatum 8X 12.50%, Naphthalinum 8X 12.50%, Sabadilla 8X 12.50%, Urtica Urens 8X 12.50%, Wyethia Helenioides 8X 12.50%, Histaminum Hydrochloricum 12X 12.50%.

Purpose

Allium Cepa – runny, stuffy nose,* Euphrasia Officinalis – teary, itchy eyes,* Kali Iodatum – sinus pain,* Naphthalinum – sneezing, red skin,* Sabadilla - headaches,* Urtica Urens – swelling, redness,* Wyethia Helenioides – hacking cough, itching,* Histaminum Hydrochloricum – congestion, swelling.*


Medication Information

Purpose

Allium Cepa – runny, stuffy nose,* Euphrasia Officinalis – teary, itchy eyes,* Kali Iodatum – sinus pain,* Naphthalinum – sneezing, red skin,* Sabadilla - headaches,* Urtica Urens – swelling, redness,* Wyethia Helenioides – hacking cough, itching,* Histaminum Hydrochloricum – congestion, swelling.*

Description

(in each drop) Allium Cepa 8X 12.50%, Euphrasia Officinalis 8X 12.50%, Kali Iodatum 8X 12.50%, Naphthalinum 8X 12.50%, Sabadilla 8X 12.50%, Urtica Urens 8X 12.50%, Wyethia Helenioides 8X 12.50%, Histaminum Hydrochloricum 12X 12.50%.

Uses:

May temporarily relieve seasonal and environmental allergies such as runny nose, itchy eyes, sinus pressure, and puffy skin.*

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

Purposes:

Allium Cepa – runny, stuffy nose,* Euphrasia Officinalis – teary, itchy eyes,* Kali Iodatum – sinus pain,* Naphthalinum – sneezing, red skin,* Sabadilla - headaches,* Urtica Urens – swelling, redness,* Wyethia Helenioides – hacking cough, itching,* Histaminum Hydrochloricum – congestion, swelling.*

Warnings:

For oral use only. If pregnant or breast-feeding, ask a health care 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

Questions:

www.HomeopathyStore.com

(888) 405-7551

Dist. by Ratis, LLC

1201 N Orange St,

Ste 7594

Wilmington, DE 19801

Directions:

• Adults: 2 sprays 3 times a day or as needed

• Children under 12: 1 spray as above

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

Store in a cool, dry place

Active Ingredients:

(in each drop) Allium Cepa 8X 12.50%, Euphrasia Officinalis 8X 12.50%, Kali Iodatum 8X 12.50%, Naphthalinum 8X 12.50%, Sabadilla 8X 12.50%, Urtica Urens 8X 12.50%, Wyethia Helenioides 8X 12.50%, Histaminum Hydrochloricum 12X 12.50%.

Inactive Ingredients:

Demineralized water, glycerin, 10% organic ethanol

Package Lable Display:

LACTOSE FREE

ANNA

KARE

Allergy Escape

ALLERGY RELIEF*

HOMEOPATHIC ORAL SPRAY

1FL. OZ (30ML)

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 seasonal and environmental allergies such as runny nose, itchy eyes, sinus pressure, and puffy skin.*

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

Purposes: (PURPOSES:)

Allium Cepa – runny, stuffy nose,* Euphrasia Officinalis – teary, itchy eyes,* Kali Iodatum – sinus pain,* Naphthalinum – sneezing, red skin,* Sabadilla - headaches,* Urtica Urens – swelling, redness,* Wyethia Helenioides – hacking cough, itching,* Histaminum Hydrochloricum – congestion, swelling.*

Warnings: (WARNINGS:)

For oral use only. If pregnant or breast-feeding, ask a health care 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

Questions: (QUESTIONS:)

www.HomeopathyStore.com

(888) 405-7551

Dist. by Ratis, LLC

1201 N Orange St,

Ste 7594

Wilmington, DE 19801

Directions: (DIRECTIONS:)

• Adults: 2 sprays 3 times a day or as needed

• Children under 12: 1 spray as above

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

Store in a cool, dry place

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) Allium Cepa 8X 12.50%, Euphrasia Officinalis 8X 12.50%, Kali Iodatum 8X 12.50%, Naphthalinum 8X 12.50%, Sabadilla 8X 12.50%, Urtica Urens 8X 12.50%, Wyethia Helenioides 8X 12.50%, Histaminum Hydrochloricum 12X 12.50%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, glycerin, 10% organic ethanol

Package Lable Display: (PACKAGE LABLE DISPLAY:)

LACTOSE FREE

ANNA

KARE

Allergy Escape

ALLERGY RELIEF*

HOMEOPATHIC ORAL SPRAY

1FL. OZ (30ML)

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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