FDA.reportPublic FDA data

85248-026update

Manufacturer
Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-22 05:10:05

Label at a glance#

ProductREDCOOL Arnica Bruise
Active ingredientARNICA MONTANA
Label structure12 sections

Dosage and administration

Apply a thin layer of arnica bruise cream to the affected area 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 arnica bruise cream.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica montana HPUS 7%

Purpose

OTC - PURPOSE SECTION

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

Use

INDICATIONS & USAGE SECTION

Temporarily relieves muscle pain and stiffness due to: ·cminor injuries ·overexertion ·falls Reduces symptoms of bruising such as: ·Pain·Swelling ·discoloration

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use if you are allergic to arnica bruise cream or to any of this product's inactive ingredients.

When Using

OTC - WHEN USING SECTION

When using this product avoid contact with eyes, mucous membranes, wounds，damaged or irritated skin.Use only as directed .Stop use if excessive skin irritation occurs.
Do not tightly wrap or bandage the treated area. Do 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of arnica bruise cream to the affected area 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 arnica bruise cream.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water,Carbomer.Sodium Hydroxide, Vanilly Butyl Ether

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-02685248-026-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
CARBOMER0A5MM307FCIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-29full-release2026-06-01 01:35:51

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
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
ndc (package): 85248-026-01
ndc (product): 85248-026
ndc11 (package): 85248002601
spl id: 5707c417-b73e-4bba-e063-6294a90a891e
spl set id: 49911392-e55e-1a6b-e063-6394a90a9af0

Reported adverse events (FAERS/openFDA)#

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