FDA Label for Avcoo Menthol Pain Relief Patch
View Indications, Usage & Precautions
Avcoo Menthol Pain Relief Patch Product Label
The following document was submitted to the FDA by the labeler of this product Adp Health Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
AVCOO Menthol Pain Relief Patch
Otc - Active Ingredient
Menthol 5%
Otc - Purpose
Topical anesthetic
Indications & Usage
for the temporary pain relief
Warnings
For external use only
Otc - Do Not Use
If you are allergic to the listed ingredients
If you are pregnent or breast feeding
If you are under 12 years of age
On wounds, cuts, damaged/broken/irritated skin
On eyes or mucous membranes
With heating pads/devices or wrap with a bandage
With other topical analgesics
If the package arrives damaged or opened.
Otc - When Using
Use only as directed
Read and follow all directions and warnings on this label
avoid contact with the eyes and mucous membranes
rare cases of serious burns have been reported with products of this type
a transient burning sensation may occur upon application but generally disappears in several days
dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Otc - Stop Use
You are experiencing pain, swelling or blistering
Redness is persent or irritation develops
Symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
If ingested, get medical help or contact a Poison Control Center right away.
Dosage & Administration
■ Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the ■ Do not repeatedly use or repeatedly reapply the patch as far as possible
■ Cut first if if used on joints
■ Use in te affected area no more than 4 times daily
■ Wash hands with cool water after use
Storage And Handling
Avoid storing patches in direct sunlight
Protect patches from excessive moisture
P lease store it at room temperature.
Inactive Ingredient
Aloe Barbadensis Leaf Extract
Arnica Montana Flower Extract
Boswellia Carterii Resin Extract
Camellia Sinensis Leaf Extract
Carboxymethylcellulose Sodium
Dihydroxyaluminum Aminoacetate
Edetate Disodium
Glycerin
Hydroxyacetophenone
Kaolin
L-Tartaric Acid
Mineral Oil
Petrolatum
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
PVP
Sodium Polyacrylate
Titanium Dioxide
Water
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