Arnica Echinacea

Arnica Echinacea
SPL v3
SPL
SPL Set ID 05b85d50-0e3e-4365-e063-6294a90a3782
Route
TOPICAL
Published
Effective Date 2024-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Flower (3 [hp_X]) Hamamelis Virginiana Top (5 [hp_X]) Echinacea, Unspecified (9 [hp_X]) Comfrey Root (6 [hp_X]) Calendula Officinalis Flowering Top Bellis Perennis Aconitum Napellus Calcium Sulfide Mercury Achillea Millefolium Chamomile Arnica Montana Atropa Belladonna St. John's Wort
Inactive Ingredients
Sorbic Acid Polyoxyl 40 Stearate Frankincense Oil Stearyl Alcohol Tea Tree Oil Myrrh Oil Water Lavender Oil Citrus Paradisi Seed Cetyl Alcohol Xanthan Gum Isopropyl Myristate Stearic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2009-09-01

Description

Directions: FOR TOPICAL USE ONLY.


Medication Information

Warnings and Precautions

Warnings: FOR EXTERNAL USE ONLY.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

Indications and Usage

Directions: FOR TOPICAL USE ONLY.

Dosage and Administration

Apply to skin as needed. Under age 2: Consult a doctor.

Description

Directions: FOR TOPICAL USE ONLY.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive Ingredients: Spring water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Distilled water, Sorbic acid, Tea tree oil, Frankincense oil, Grapefruit seed extract, Myrrh oil

Prepared using rhythmical processes.

Section 51945-4

Section 53413-1

Questions? Call 866.642.2858

Made with care by Uriel, East Troy, WI 53120

shopuriel.com Lot:

Section 55105-1

Uses: Temporary relief of bruises, sprains and minor cuts.

Section 55106-9

Active Ingredients: Arnica (Arnica e flor.) 3X, Bellis (Daisy) 5X, Echinacea (Purple coneflower) 5X, Hamamelis (Witch hazel) 5X, Hypericum (St. John’s Wort) 5X, Achillea (Yarrow) 6X, Aconitum (Monkshood) 6X, Arnica (e pl.tota) 6X, Atropa belladonna (Nightshade) 6X, Calendula (Calendula ex herba) 6X, Chamomilla (Chamomile) 6X, Hepar sulfuris (Liver of lime) 9X,

Symphytum (Comfrey) 9X, Mercurius vivus (Mercury amidonitrate) 9X


Structured Label Content

Indications and Usage (34067-9)

Directions: FOR TOPICAL USE ONLY.

Dosage and Administration (34068-7)

Apply to skin as needed. Under age 2: Consult a doctor.

Warnings and Precautions (34071-1)

Warnings: FOR EXTERNAL USE ONLY.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive Ingredients: Spring water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Distilled water, Sorbic acid, Tea tree oil, Frankincense oil, Grapefruit seed extract, Myrrh oil

Prepared using rhythmical processes.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 866.642.2858

Made with care by Uriel, East Troy, WI 53120

shopuriel.com Lot:

Section 55105-1 (55105-1)

Uses: Temporary relief of bruises, sprains and minor cuts.

Section 55106-9 (55106-9)

Active Ingredients: Arnica (Arnica e flor.) 3X, Bellis (Daisy) 5X, Echinacea (Purple coneflower) 5X, Hamamelis (Witch hazel) 5X, Hypericum (St. John’s Wort) 5X, Achillea (Yarrow) 6X, Aconitum (Monkshood) 6X, Arnica (e pl.tota) 6X, Atropa belladonna (Nightshade) 6X, Calendula (Calendula ex herba) 6X, Chamomilla (Chamomile) 6X, Hepar sulfuris (Liver of lime) 9X,

Symphytum (Comfrey) 9X, Mercurius vivus (Mercury amidonitrate) 9X


Advanced Ingredient Data


Raw Label Data

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