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ARNICA MONTANA 30C - 3-PACK

Approved
Approval ID

2cef6a91-d300-18e6-e063-6394a90ab88f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

SEVENE USA

DUNS: 969332936

Products 1

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

ARNICA MONTANA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76472-5000
Product Classification
G
Generic Name
ARNICA MONTANA
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (2)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
ARNICA MONTANAActive
Quantity: 30 [hp_C] in 1 1
Code: O80TY208ZW
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/15/2025

PRINCIPAL DISPLAY PANEL

ARNICA 30C 3P P1ARNICA 30C 3P P2ARNICA 30C 3P P3ETUI ARNICA 30C 3P P1ETUI ARNICA 30C 3P P2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/15/2025

TRADITIONALLY USED FOR

Pain from muscle soreness, stiffness, swelling - bruises*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/15/2025

ACTIVE INGREDIENT

HOMEOPATHIC DILUTION OF ARNICA MONTANA 30c

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/15/2025

DIRECTIONS

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/15/2025

USE

Condition listed above or as directed by a physician.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/15/2025

WARNINGS

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/15/2025

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/15/2025

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/15/2025

OTHER INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/15/2025

DO NOT USE

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/15/2025

INCACTIVE INGREDIENTS

Sucrose.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/15/2025

QUESTIONS?

info@ollois.com * www.ollois.com * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

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ARNICA MONTANA 30C - 3-PACK - FDA Drug Approval Details