The following Structured Product Label (SPL) was submitted to the FDA by Aec Consumer Products for the product Pain Relief Cream (NDC 86089-222). 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 otc - active ingredient, purpose, warning, when using this product, stop use and ask a doctor if, keep out of use of children, storage and handling, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient Purpose
Lidocaine Hydrochloride 4%.......................................................................External Analgesic
External Analgesic
For External use only
When using this product use only as directed
Stop use and ask a doctor if condition worsens symptoms persist more than 7 days
symptoms clear up and occur again with a few days
Keep out of use of children. If swallowed, get medical help or contact a Poison Control Center right away
Apply as needed to affectedareas 3-4 times a day.
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aqua, Arnica Mountain Flower Extract, Astaxanthin, Benzyl Alcohol, BHT, Bisabolol, Boswellia Serrata Resin Extract, Cannabis Sativa Oil/Extract, Cetyl Alcohol, Citrus Aurantium Bergamia Peel Oil, Curcurria Longa Root Extract, Cyclopentasiloxane, Dimethicone, Dimethicol, Emu Oil, Ethoxydiglycol, Glucosamine, Glycerin, Glyceryl Stearate SE, Isopropyl Palmitate, Melaleuca Alternifolia Leaf Oil, Methylsulfonylmethane, PEG-100 Stearate, Phenoxyethanol, Polyquaterium-10, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate, Salicylic Acid, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopherol, Triethanolamine, Vaccinium Myrtillus Fruit/Leaf Extract
Use
For the temporary relief of pain
Do not use in large quantities, particularly over raw or blistered surfaces for more than one week without consulting a doctor
Ask a doctor if condition worsens symptoms persist more than 7 days symptoms clear up and occur again with a few days
Adults and children over 12 years: apply as needed to affected areas 3-4 times a day. Consult a physician if pain persists.
Apply as needed to affected areas 3-4 times a day.
Image Of Label (Lidocaine)
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