FDA Label for Theracare 4% Lidocaine Cream
View Indications, Usage & Precautions
Theracare 4% Lidocaine Cream Product Label
The following document was submitted to the FDA by the labeler of this product Veridian Healthcare. 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
TheraCare 4% Lidocaine Cream. 2.7 oz
Drug Facts
Active Ingredient
Lidocaine HCI 4%
Purpose
Lidocaine HCl 4%............................................................................................................................Topical anesthetic
Use
temporarily relieves minor pain
Warnings
For external use only
Avoid contact with eyes
Do Not Use
■ on large areas of the body or on cut, irritated or swollen skin
■on puncture wounds
■ for more than one week without consulting a doctor
When Using This Product
■ use only as directed. Read and follow all directions and warning on this carton.
■ do not allow contact with the eyes
■ do not bandage or apply local heat (such as heating pads) to the area of use
Stop Use And Ask A Doctor If
■ condition worsens
■ symptoms persist for 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 (1-800-222-1222) right away.
Directions
adults and children over 12 years:
■ apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period
■ children 12 years or younger: ask a doctor
Inactive Ingredients
aloe vera leaf, carbopol 940, cetostearyl alcohol, dimethicone 350, edetate disodium, glycerin, glyceryl monostearate, isopropyl alcohol, phenoxyethanol, polysorbate 60, steareth 2, steareth 21, water
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