Otc - Active Ingredient
Arnica montana 1X HPUS 7%
Arnica Bruise Cream
FDA Label NDC 88028-003
12 label sections · Submitted to the FDA by Shenzhen Fanyi Era Technology Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Fanyi Era Technology Co., Ltd for the product Arnica Bruise (NDC 88028-003). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Otc - Purpose
Reduces minor pain, swelling, & discoloration from bruises
Indications & Usage
Helps relieve minor pain, swelling, and discoloration associated with bruising.
Warnings
For external use only.
Otc - Do Not Use
Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.
Otc - When Using
When using this product
■ avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
■ 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
Otc - Stop Use
Stop use and ask a doctor if
■ excessive irritation or rash develops
■ condition persists for more than 3 days or worsens
■ symptoms clear up and occur again within a few days
■ you are pregnant or nursing
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
■ Apply a thin layer to the affected area as soon as possible after minor injury.
■ Apply up to 3 times daily as needed. If using heat or cold therapy, wait 5 minutes before applying.
■ Gently massage until absorbed. Wash hands after use.
■ Children under 3 years of age: Not recommended.
Other Safety Information
■ Before use, read all information on carton and enclosed leaflet
■ Keep the carton. It contains important information.
■ Keep tightly closed.
Inactive Ingredient
Water, Glycerin, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Vitis Vinifera (Grape) Seed Oil, Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Niacinamide (Vitamin B3), Carbomer, Cetearyl Alcohol, Glyceryl Stearate, Dimethicone, Ethylhexylglycerin, Phenoxyethanol, Sodium Hydroxide
Package Label.Principal Display Panel
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