arnica calendula wound

arnica calendula wound
SPL v1
SPL
SPL Set ID 38cfd292-4dbd-2caf-e063-6394a90a0527
Route
topical
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calendula officinalis flowering top (1 [hp_X]) arnica montana echinacea, unspecified silica antimony
Inactive Ingredients
diatomaceous earth

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. Contains lactose. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

Active Ingredient

Active Ingredients: 100gm contains: 25gm Arnica montana MT, 16.5gm Calendula ex herba MT, 16.6gm Echinacea angustifolia MT (Purple coneflower), 1gm Silicea (Quartz), 1gm Stibium metallicum (Antimony)

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: Diatomaceous Earth

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

Use: Temporary relief of superficial wounds and eczema.


Structured Label Content

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. Contains lactose. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

Active Ingredient (55106-9)

Active Ingredients: 100gm contains: 25gm Arnica montana MT, 16.5gm Calendula ex herba MT, 16.6gm Echinacea angustifolia MT (Purple coneflower), 1gm Silicea (Quartz), 1gm Stibium metallicum (Antimony)

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.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive Ingredient: Diatomaceous Earth

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)

Use: Temporary relief of superficial wounds and eczema.


Advanced Ingredient Data


Raw Label Data

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