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Generic: lidocaine lotion is used for the treatment of Adams-Stokes Syndrome Burns Esophageal Diseases Hypersensitivity Mouth Diseases Pain Tachycardia, Paroxysmal Ventricular Fibrillation Tachycardia, Ventricular Ventricular Premature Complexes Drug-Related Side Effects and Adverse Reactions

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Active Ingredient


Lidocaine 4%

Uses


For temporary relief of pain & inflammation

Uses


for temporary relief of pain & inflammation

Directions


Use only as directed. Adults & children 12 years or older: apply evenly to affected area not more than 3-4 x daily. For children under 12 years, consult with doctor for recommendations.

Change in heading as requested after review of draft


The Indications and Directions section was renameded to Dosage and Administration. This was noted as required 34068-7 This change was made on 7/21/2022 as directed.

07/26/22-- As per validation request, changed Directions to come under Dosage and Administration.

Warnings Section


For External use only.

Do not use:on wounds, raw surfaces or bulered areas, with a heating pad, or if allergic to product ingredients

When using this product:Avoid eye contact; do not use excessive amounts; do not exceed recommended dosage unless directed by doctor; do not bandage applied area.

Stop and ask doctor if:an allergic reaction occurs; condition worsens or does not improve within 7 days.

If pregnant or breast-feeding:consult with doctor before use.

if swallowed, get medical help or contact a Poison Control Center.

Precautions Concerning Children


Keep out of reach of children.

Other Information:


Store at 20 o- 25 oC (68 o- 77 oF),. Protect from freezing or storing in direct sunlight.

Inactive Ingredient Section


Arnica Montanaflower extract, cetearyl alcohol, cetyl ester waxes, cyclopentasiloxane, disodium EDTA, ethoxydiglycol, fragrance, Helianthus annuus(sunflower) oil, Lavandula Angustifolio(lavender) oil, methylparaben, PEG40 hydrogenated caster oil, poly(acrylic acid) 2-propionic acid homopolymer, propylene glycol, propylparaben, tetrahydrocurcumin, tocopherol acetate, triethanolamine, water.

Questions And Comments


www.optimallabortories.com

(212) 535-1700

Package Label And Principal Display Panel Vonaflex


NDC 36590-6451-03 front & back label

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"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."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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