Otc - Active Ingredient
Active Ingredients
Camphor 3.100%
Menthol 3.000%
Arneu
FDA Label NDC 42046-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cc Medical Devices Inc for the product Arneu (NDC 42046-002). 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 - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical Analgesic
Topical Analgesic
Indications & Usage
Uses
For the temporary relief of minor aches and pains of muscles and joints.
Penetrating pain relief.
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not bandage tightly.
Do not apply heat to the area of application.
Do not apply to open wounds or damaged skin.
Otc - When Using
Avoid contact with eyes or mucous membranes.
Otc - Ask Doctor
Ask a doctor before use, if you have ever experienced a reaction due to ingredients listed.
Otc - Stop Use
Stop use and consult a licensed health professional if conditions worsens or if symptoms persists for more than 7 days, or clears up and occurs again.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask the health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If ingestion occurs, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Adults and children 12 years of age or older
Apply to surface, leaving a thin visible film; by applying a thicker film, the intensity is increased.
Apply to the area of pain, extending outside of the area slightly.
Apply 2 times a day minimum (do not exceed application of 4 times daily).
Allow to dry completely before applying loose clothing over the area.
Directions
(Children 12 years of age or younger)
Ask your doctor or a licensed health professional.
Storage And Handling
Other Information
Store at 15-30 C (50-85 F). Keep sealed tightly.
No triethanolamine used in manufacturing.
Have all medical diagnosis confirmed by a healthcare professional before treating.
Do not use if cap seal has been tampered with.
Inactive Ingredient
Inactive Ingredients
Water, propylene glycol, glycerin, witch hazel, carbomer, sodium hydroxymethylglycinate, fragrance, arnica montana flower extract, potassium asparate, sodium chlorite, willow bark extract, green tea leaf extract, sodium hydroxide, spirulina maxima extract, aloe vera leaf juice, ginger root extract, bromelain, boswellia serrata gum, sodium sesquicarbonate, sodium bicarbonate, capsaicin (capsicum frutescens fruit extract).
Package Label.Principal Display Panel
ArNeu
penetrating pain relief
God Formula
Topical Analgesic Counterirritant
For the Temporary Relief of Minor Aches and Pains of Muscles and Joints
NET WT. 3.0 OZ. (85 g.)
www.arneu.com
NDC 42046-002-03
US Pat.7,704,522 and Pat. Pending
Made in USA
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