{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Aspercreme with Lidocaine No-Mess Applicator Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) ALCOHOL ALOE VERA LEAF AMINOMETHYLPROPANOL C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER CAPRYLYL TRISILOXANE CETOSTEARYL ALCOHOL CETETH-20 PHOSPHATE DICETYL PHOSPHATE DIMETHICONE EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GLYCERYL STEARATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) ISOHEXADECANE METHYLPARABEN POLYSORBATE 60 STEARETH-2 STEARETH-21 WATER Aspercreme with lidocaine No-Mess Applicator Two Pack Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) ALCOHOL ALOE VERA LEAF AMINOMETHYLPROPANOL C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER CAPRYLYL TRISILOXANE CETOSTEARYL ALCOHOL CETETH-20 PHOSPHATE DIHEXADECYL PHOSPHATE DIMETHICONE EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GLYCERYL STEARATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) ISOHEXADECANE METHYLPARABEN POLYSORBATE 60 STEARETH-2 STEARETH-21 WATER" ], "spl_unclassified_section": [ "ASPERCREME with LIDOCAINE NO-MESS APPLICATOR Drug Facts" ], "active_ingredient": [ "Active ingredient" ], "purpose": [ "Purpose Lidocaine HCl 4%............................................................................................................. Topical anesthetic" ], "indications_and_usage": [ "Use for the temporary relief of pain" ], "warnings": [ "Warnings For external use only Flammable ■ keep away from heat and open 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." ], "do_not_use": [ "Do not use ■ in large quantities ■ on wounds or on irritated or damaged skin ■ with a heating pad" ], "when_using": [ "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": [ "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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions ■ adults and children 12 years of age and older: ■ apply a thin layer to affected area using roller ball every 6 to 8 hours, not more than 3 to 4 times daily ■ massage as needed ■ if product unintentionally gets on hands, wash hands thoroughly with soap and water after each use ■ children under 12 years of age: ask a doctor" ], "inactive_ingredient": [ "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, steareth-2, steareth-21, water Child-resistant packaging. Replace cap after each use. Keep carton as it contains important product information." ], "package_label_principal_display_panel": [ "Principal Display Panel MAX STRENGTH Aspercreme with 4% L IDOCAINE PAIN RELIEF LIQUID 2.5 fl oz (73 mL) Principal Display Panel MAX STRENGTH Aspercreme with 4% LIDOCAINE PAIN RELIEF LIQUID 2.5 fl oz (73 mL)", "Principal Display Panel Aspercreme Lidocaine Pain Relief Liquid 2.5 fl oz (73 mL) – 2 Pack Principal Display Panel Aspercreme Lidocaine Pain Relief Liquid 2.5 fl oz (73 mL) – 2 Pack" ], "set_id": "8092cde7-28d0-4755-b5c0-5765934e572f", "id": "9314317c-21e4-4173-a0c9-cec85d6dd98c", "effective_time": "20260529", "version": "10", "openfda": { "application_number": [ "M017" ], "brand_name": [ "Aspercreme with Lidocaine No-Mess Applicator", "Aspercreme with lidocaine No-Mess Applicator Two Pack" ], "generic_name": [ "LIDOCAINE HYDROCHLORIDE" ], "manufacturer_name": [ "Chattem, Inc." ], "product_ndc": [ "41167-0581", "41167-0599" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "LIDOCAINE HYDROCHLORIDE" ], "rxcui": [ "1987647" ], "spl_id": [ "9314317c-21e4-4173-a0c9-cec85d6dd98c" ], "spl_set_id": [ "8092cde7-28d0-4755-b5c0-5765934e572f" ], "package_ndc": [ "41167-0581-0", "41167-0581-5", "41167-0599-9" ], "is_original_packager": [ true ], "unii": [ "V13007Z41A" ] } } ] }