MedPath

Arnica Echinacea

Arnica Echinacea

Approved
Approval ID

3e4e07c5-6947-a502-e063-6294a90ab866

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 8, 2025

Manufacturers
FDA

Uriel Pharmacy, Inc

DUNS: 043471163

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Arnica Echinacea

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-1406
Product Classification
G
Generic Name
Arnica Echinacea
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2025
FDA Product Classification

INGREDIENTS (23)

ATROPA BELLADONNAActive
Quantity: 6 [hp_X] in 1 g
Code: WQZ3G9PF0H
Classification: ACTIB
HAMAMELIS VIRGINIANA TOPActive
Quantity: 5 [hp_X] in 1 g
Code: UDA30A2JJY
Classification: ACTIB
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
FRANKINCENSE OILInactive
Code: 67ZYA5T02K
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
ARNICA MONTANAActive
Quantity: 6 [hp_X] in 1 g
Code: O80TY208ZW
Classification: ACTIB
BELLIS PERENNISActive
Quantity: 5 [hp_X] in 1 g
Code: 2HU33I03UY
Classification: ACTIB
ARNICA MONTANA FLOWERActive
Quantity: 3 [hp_X] in 1 g
Code: OZ0E5Y15PZ
Classification: ACTIB
MYRRH OILInactive
Code: H74221J5J4
Classification: IACT
CHAMOMILEActive
Quantity: 6 [hp_X] in 1 g
Code: FGL3685T2X
Classification: ACTIB
ACONITUM NAPELLUSActive
Quantity: 6 [hp_X] in 1 g
Code: U0NQ8555JD
Classification: ACTIB
CALCIUM SULFIDEActive
Quantity: 9 [hp_X] in 1 g
Code: 1MBW07J51Q
Classification: ACTIB
ST. JOHN'S WORTActive
Quantity: 5 [hp_X] in 1 g
Code: UFH8805FKA
Classification: ACTIB
MERCURYActive
Quantity: 9 [hp_X] in 1 g
Code: FXS1BY2PGL
Classification: ACTIB
ACHILLEA MILLEFOLIUMActive
Quantity: 6 [hp_X] in 1 g
Code: 2FXJ6SW4PK
Classification: ACTIB
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 6 [hp_X] in 1 g
Code: 18E7415PXQ
Classification: ACTIB
COMFREY ROOTActive
Quantity: 9 [hp_X] in 1 g
Code: M9VVZ08EKQ
Classification: ACTIB
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ECHINACEA, UNSPECIFIEDActive
Quantity: 5 [hp_X] in 1 g
Code: 4N9P6CC1DX
Classification: ACTIB
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/9/2025

Arnica Echinacea Ointment

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/9/2025

Directions: FOR TOPICAL USE ONLY.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/9/2025

Inactive Ingredients: Sunflower seed oil, Lanolin, Beeswax, Lanolin alcohol, Lavender oil, Distilled water, Tea tree oil, Frankincense oil, Myrrh oil

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/9/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/9/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/9/2025

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 (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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/9/2025

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/9/2025

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/9/2025

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
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