ACOLYE ARNICA BRUISE

Manufacturer
Jiangxi Hemei Pharmaceutical Co., Ltd
Effective date
2025-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:34:29

Label at a glance#

ProductACOLYE ARNICA BRUISE
Active ingredientARNICA MONTANA
Label structure13 sections

Dosage and administration

Apply a thin layer of Arnicare Cream to affected area and massage gently as soon as possible after minor injury, Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying Arnicare Cream.

Storage and handling

■Do not use if package is damaged ■ Store at 68-77°F(20-25°C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 1X HPUS 7%

Purpose

OTC - PURPOSE SECTION

Relieves muscle pain & stiffness,swelling.from injuries, discoloration from bruises
The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

if you are allergic to Arnica montana or to any of this product's inactive ingredients.

When Using

OTC - WHEN USING SECTION

■Avoid contact with eyes, mucous membranes, wounds.damaged or irritated skin, ■Use only as directed, ■Do not tightly wrap or bandage the treated area■ not apply heat or ice to the treated area immediately before or after use.

Stop Use

OTC - STOP USE SECTION

■Condition persists for more than 3 days or worsens.
■Symptoms clear up and occur again within a few days.

Ask Doctor

OTC - ASK DOCTOR SECTION

■Condition persists for more than 3 days or worsens.
■Symptoms clear up and occur again within a few days.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Use

INDICATIONS & USAGE SECTION

Temporarily relieves muscle pain and stiffness due to:■minor injuries ■overexertion ■falls
redues symptoms of bruising such as:■pain■swelling■discoloration

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of Arnicare Cream to affected area and massage gently as soon as possible after minor injury, Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying Arnicare Cream.

Other information

STORAGE AND HANDLING SECTION

■Do not use if package is damaged ■ Store at 68-77°F(20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerol, Propylene Glycol, Carbomer, Centella Asiatica 0il, Lavender Oil, VitaminK/E/C, Coconut 0il, Glyceryl Monostearate, Cetyl Alcohol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84010-18784010-187-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4a47d5a4-7d2c-1550-e063-6394a90ace0a3f74120d-6de0-96c9-e063-6294a90a7a092026-02-07WarningsExact identifier
spl set id: 3f74120d-6de0-96c9-e063-6294a90a7a09

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.