MedPath

HEALSURE PAIN RELIEF

84010-124

Approved
Approval ID

36066488-0bf3-05c7-e063-6394a90a3baa

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 26, 2025

Manufacturers
FDA

Jiangxi Hemei Pharmaceutical Co., Ltd

DUNS: 724892056

Products 1

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

Arnica montana HPUS 7% PAIN RELIEF

PRODUCT DETAILS

NDC Product Code84010-124
Application NumberM017
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 26, 2025
Generic NameArnica montana HPUS 7% PAIN RELIEF

INGREDIENTS (6)

ARNICA MONTANAActive
Quantity: 7 g in 100 g
Code: O80TY208ZW
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT
VANILLYL BUTYL ETHERInactive
Code: S2ULN37C9R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/26/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/26/2025

Use

Temporarily relieves muscle pain and stiffness due to:

■Minor injuries■Overexertio

Also helps reduces symptoms of bruising such as:

■Pain■Swelling■Discoloration

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/26/2025

Active Ingredient

Arnica montana HPUS7%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/26/2025

Purpose

Relieves muscle pain & stiffness,swelling from injuries, discoloration from bruises

WARNINGS SECTION

LOINC: 34071-1Updated: 5/26/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/26/2025

Do not use

Do not use if you are allergic to healsure or to any of this product's inactive ingredients

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/26/2025

When Using

When using this product avoid contact with eyes, mucous membranes, wounds damaged or irritated skin.Use only as directed. Dryness or irritation may occur
Do not tightly wrap or bandage the treated area. Do not apply heat or ice to treated area immediately before or after use

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/26/2025

Stop Use

if teh ocondition persists for more than 3 days or worsensosor if symptoms clear up and then retum within a few days.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/26/2025

Ask Doctor

if teh ocondition persists for more than 3 days or worsensosor if symptoms clear up and then retum within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/26/2025

Keep Out Of Reach Of Children

lf swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/26/2025

Directions

Apply a thin layer of dermfree cream to the affected area as soon as possible after minor injury. Repeat 3 times a day or asneeded.lf heat or ice is applied, wait 5 minutes before applying dermfree cream.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/26/2025

Inactive ingredients

Purifed Water, Alcohol, Carbomer, Sodium Hydroxide, Vanillyl Butyl Ether

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HEALSURE PAIN RELIEF - FDA Drug Approval Details