MedPath

Recuren Plus Arnica Bruise Cream

Approved
Approval ID

3dbe6e5b-1ca7-6941-e063-6294a90ab042

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 1, 2025

Manufacturers
FDA

REGENEREN PLUS LTD

DUNS: 226204743

Products 1

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

Arnica Montana 7%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87014-002
Product Classification
G
Generic Name
Arnica Montana 7%
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 1, 2025
FDA Product Classification

INGREDIENTS (11)

BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
AQUAInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
COCOS NUCIFERA (COCONUT) OILInactive
Code: Q9L0O73W7L
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT
ARNICA MONTANAActive
Quantity: 7 g in 100 g
Code: O80TY208ZW
Classification: ACTIB
PHYTONADIONEInactive
Code: A034SE7857
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

Package

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2025

For the temporary relief of pain, swelling, and discoloration due to minor bruising, muscle overexertion, or skin discomfort.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Arnica montana 1X HPUS 7%

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/23/2025

Relieves for Minor Bruises, Muscle Soreness & Swelling from injuries,discoloration associated with bruising.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/23/2025

For external use only.

if you are allergic to Arnica Montana or any of the ingredients.

Avoid contact with eyes, mucous membranes, or broken skin.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 3 days.

Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/23/2025

Apply a thin layer to the affected area 2–3 times daily. Gently massage into fragile or delicate skin areas. If heat or ice is applied, wait 5 minutes before applying Arnica Bruise Cream.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/23/2025

Store at 68°–77°F(20°–25°C). Protect from heat and direct sunlight.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/23/2025

Aqua (Purified Water), Glycerin, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Ethanol,Carbomer, Sodium Citrate, Sodium Hydroxide, Phytonadione (Vitamin K1), Sodium Benzoate.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/23/2025

Email at: service@recurenplus.co.uk

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