Purpose
Lidocaine HCl 4%............................................................................................................................Topical anesthetic
Aspercreme Lidocaine With Eucalyptus Essential Oil Cream
FDA Label NDC 41167-0566
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Aspercreme Lidocaine With Eucalyptus Essential Oil (NDC 41167-0566). 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 purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Use
for the temporary relief of pain
Warnings
For external use only
Flammable: keep away from fire or flame.
Do Not Use
■ in large quantities
■ on wounds or on irritated or damaged skin
■ with a heating pad
When Using This Product
■ use only as directed
■ do not bandage tightly
■ avoid contact with eyes and mucous membranes
■ do not expose the area to local heat or to direct sunlight
Stop Use And Ask A Doctor If
■ condition worsens or symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ redness is present or excessive skin irritation occurs
■ you experience severe burning pain, swelling, or blistering where the product was applied
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 12 years of age and older:
■ apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily
■ massage until thoroughly absorbed into skin
■ wash hands thoroughly with soap and water after each use
■ children under 12 years of age: ask a doctor
Inactive Ingredients
alcohol denat. (15%), aloe barbadensis leaf juice, C15-19 alkane, caprylic/capric triglyceride, carbomer, cetearyl alcohol, citric acid, ethylhexylglycerin, eucalyptus globulus leaf oil, glycerin, glyceryl stearate, hydroxyacetophenone, potassium hydroxide, polysorbate 60, propanediol, steareth-2, steareth-21, water
373-005
Child-resistant packaging. Close cap tightly after use.
Keep carton as it contains important information.
Principal Display Panel
Aspercreme
Lidocaine with Eucalyptus Essential Oil
Numbs away pain
NET WT 3 oz (85 g)
Principal Display Panelaspercremelidocaine With Eucalyptus Essential Oilnumbs Away Painnet Wt 3 Oz (85 G) (Aspercreme Lidocaine With Eucalyptus Essential Oil 01)
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