Purpose
Lidocaine HCl 4%..........................................................................................................................Topical anesthetic
Aspercreme With Lidocaine Essential Oils Rosemary Mint Liquid
FDA Label NDC 41167-0598
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 With Lidocaine Essential Oils Rosemary Mint (NDC 41167-0598). 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
temporarily relieves minor pain
Warnings
For external use only
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 warnings on this carton.
■ do not allow contact with the eyes and mucous membranes
■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
■ do not use at the same time as other topical analgesics
Stop Use And Ask A Doctor If
■ condition worsens
■ redness is present
■ irritation develops
■ symptoms persist for more than 7 days or clear up and occur again within a few days
Flammable ■ Keep away from fire or flame
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:
■ apply a thin layer to affected area not more than 3 to 4 times daily
children 12 years or younger: ask a doctor
Inactive Ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, rosemary mint fragrance, steareth-2, steareth-21, water
Child-resistant packaging. Close cap tightly after use.
Keep carton as it contains important information.
Principal Display Panel
MAX STRENGTH
Aspercreme
with 4% LIDOCAINE
2.5 FL oz (73 mL)
Principal Display Panelmax Strengthaspercremewith 4% Lidocaine2.5 Fl Oz (73 mL) (Aspercreme With Lidocaine Essential Oils Rosemary 01)
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