Betula Rhus Special Order

Betula Rhus Special Order
SPL v3
SPL
SPL Set ID 333d67a8-88e9-4a4c-945b-59d0a613d0e6
Route
TOPICAL
Published
Effective Date 2009-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Betula Pubescens Bark (2 [hp_X]) Sage (3 [hp_X]) Filipendula Ulmaria Root (4 [hp_X]) Urtica Urens (5 [hp_X]) Benzoic Acid (10 [hp_X]) Berberis Vulgaris Root Bark (12 [hp_X]) Colchicum Autumnale Whole Formica Rufa Toxicodendron Pubescens Leaf
Inactive Ingredients
Tea Tree Oil Water Stearic Acid Isopropyl Myristate Lavender Oil Cetyl Alcohol Polyoxyl 40 Stearate Stearyl Alcohol Xanthan Gum Sorbic Acid Frankincense Oil Myrrh Oil Citrus Paradisi Seed

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

Section 51945-4

Section 53413-1

Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com

Section 55105-1

Use: Temporary relief of sore muscles.

Section 55106-9

Active Ingredients: Betula cort. decoct. (Silver birch, bark dried) 2X, Salix (Willow) 2X, Spiraea ulmaria (Meadowsweet) 2X, Urtica urens (Small nettle) 2X, Acidum benzoicum (Benzoic acid) 3X, Berberis (Barberry) 4X, Colchicum (Meadow saffron) 5X, Formica (Red wood ant) 10X, Rhus tox. (Sumac) 12X


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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com

Section 55105-1 (55105-1)

Use: Temporary relief of sore muscles.

Section 55106-9 (55106-9)

Active Ingredients: Betula cort. decoct. (Silver birch, bark dried) 2X, Salix (Willow) 2X, Spiraea ulmaria (Meadowsweet) 2X, Urtica urens (Small nettle) 2X, Acidum benzoicum (Benzoic acid) 3X, Berberis (Barberry) 4X, Colchicum (Meadow saffron) 5X, Formica (Red wood ant) 10X, Rhus tox. (Sumac) 12X


Advanced Ingredient Data


Raw Label Data

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