Balsamicum

Balsamicum
SPL v1
SPL
SPL Set ID 2b6073f5-238f-eff8-e063-6294a90a581a
Route
TOPICAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Balsam Peru (1 [hp_X]) Larix Decidua Resin Mercurialis Perennis Calendula Officinalis Flowering Top Antimony
Inactive Ingredients
Sorbic Acid Olive Oil Sunflower Oil Water Lanolin Beeswax Alcohol Tea Tree 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: 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: Organic Olive oil, Lanolin, Sunflower seed oil, Yellow beeswax, Spring water, Organic cane alcohol, Sorbic acid, Tea tree oil, Grapefruit seed extract

Prepared using rhythmical processes.

Section 51945-4

Section 53413-1

Questions? Call 866.642.2858

Uriel, East Troy, WI 53120

shopuriel.com Lot:

Section 55105-1

Uses: Temporary relief of minor wounds.

Section 55106-9

Active Ingredients: Calendula essence 1X, Mercurialis essence (Dog’s mercury) 1X, Resina laricis (Larch resin) 1X, Stibium (Antimony) 1X, Peruvian balsam 1x


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: 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: Organic Olive oil, Lanolin, Sunflower seed oil, Yellow beeswax, Spring water, Organic cane alcohol, Sorbic acid, Tea tree oil, Grapefruit seed extract

Prepared using rhythmical processes.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 866.642.2858

Uriel, East Troy, WI 53120

shopuriel.com Lot:

Section 55105-1 (55105-1)

Uses: Temporary relief of minor wounds.

Section 55106-9 (55106-9)

Active Ingredients: Calendula essence 1X, Mercurialis essence (Dog’s mercury) 1X, Resina laricis (Larch resin) 1X, Stibium (Antimony) 1X, Peruvian balsam 1x


Advanced Ingredient Data


Raw Label Data

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