FDA Label for Pharmapurerx Menthotral
View Indications, Usage & Precautions
Pharmapurerx Menthotral Product Label
The following document was submitted to the FDA by the labeler of this product Puretek Corporation. 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.
Active Ingredients (% W/W)
Lidocaine 3.88%
Menthol 3%
Purposes
Topical Anesthetic (Lidocaine 3.88%)
Topical Analgesic (Menthol 3%)
Uses
for the temporary relief of minor pain, itching and irritation due to / associated with
■ simple backache ■ arthritis ■ sprains ■ muscle strains ■ bruises
■ minor cuts/scrapes ■ minor burns/sunburn ■ insect bites
Warnings
For external use only
Do Not Use
■ if allergic to lidocaine or any other local anesthetics
■ over a large skin area ■ on deep puncture wounds ■ on infections
■ on raw surfaces or blistered areas
When Using This Product
■ do not get into eyes ■ do not use in large quantities
■ do not bandage or apply heat to treated areas
■ wash hands immediately after using
Stop Use And Ask A Doctor If
■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ Adults and children over 12 years of age: apply a thin layer to the affected area up to 3 to 4 times a day
■ Children 12 years of age or younger: consult a doctor
Other Information
■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
Aminomethyl Propanol, Carbomer, Ceteareth-20, Cetyl Ethylhexanoate, Cetyl Phosphate, Diisobutyl Adipate, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate SE, Phenoxyethanol, Purified Water, Stearic Acid.
* Please review the disclaimer below.