Active Ingredient
Arnica montana HPUS 7%
Redcool Arnica Bruise Cream
FDA Label NDC 85248-026
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Zhongletang Pharmaceuticals Co.,ltd. for the product Redcool Arnica Bruise (NDC 85248-026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Relieves muscle pain & stiffness，swelling from injuries, discoloration from bruises
Use
Temporarily relieves muscle pain and stiffness due to: ·cminor injuries ·overexertion ·falls Reduces symptoms of bruising such as: ·Pain·Swelling ·discoloration
Warnings
For external use only
Do Not Use
Do not use if you are allergic to arnica bruise cream or to any of this product's inactive ingredients.
When Using
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
Condition persists for more than 3 days or worsens, Symptoms clear up and occur again within a few days.
Ask Doctor
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
lf swallowed, get medical help or contact a Poison control center right away.
Directions
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
Purified water,Carbomer.Sodium Hydroxide, Vanilly Butyl Ether
Principal Display Panel
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