Active Ingredient
Arnica Montana 1X HPUS 7%
Supreh Arnica Bruise Cream
FDA Label NDC 83818-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Supreh Arnica Bruise Cream (NDC 83818-025). 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 this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Reduces pain, swelling, and discoloration from bruises
Use
reduces symptoms of bruising such as: 1. pain 2. swelling 3. discoloration
Warnings
For external use only
Do Not Use
if you are allergic to Arnica montana or to any of this product's inactive ingredients.
When Using This Product
• avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
• use only as directed
• 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 And Ask A Doctor If
• condition persists for more than 3 days or worsens
• symptoms clear up and occur again within a few days.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply a thin layer of the cream to affected area and massage gently as soon as possible after minor bruise. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying the cream.
Other Information
• Store at room temperature (20–25 °C / 68–77 °F).
• Protect from freezing and excessive heat.
Inactive Ingredients
Aqua (Water), Niacinamide, Ceramide NP, Aloe Barbadensis Leaf Extract, Propylene Glycol, Tocopherol (Vitamin E), Phytonadione (Vitamin K1), Ascorbic Acid (Vitamin C), Ceramide AP, Phenoxyethanol, Carbomer, Triethanolamine
Questions Or Comments?
Please contact [email protected]
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