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Drug Facts
Lidoxi Ointment
FDA Label NDC 87239-1111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by T&t Pharma Holdings Llc for the product Lidoxi (NDC 87239-1111). 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 other, active ingredients, purpose, uses, warnings:, allergy alert, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine 4%
Purpose
Local Anesthetic
Uses
For the temporary relief of muscle pain and joint pain associated with:
-Backache -Cramps -Soreness -Strains -Discomfort -Neckache
Warnings:
For External Use Only
Allergy Alert
Local anesthetics may cause methemoglobinemia. If an allergic reaction occurs, stop use and seek medical attention immediately.
Do Not Use
- On damaged, irritated, or infected skin
- With a bandage or heating pad
- If you are allergic to any ingredients in this product
- In the eyes, nose, or mouth
- Otherwise as directed
When Using This Product
Avoid contact with the eyes, nose, and mouth
Stop Use And Ask Doctor If
- Any of the Warnings apply to you
- Excessive skin irritation develops
- Condition worsens
- Symptoms persist for more than 7 days, or symptoms clear up and occur aqain within 3 days
If Pregnant Or Breast-Feeding
Ask a healthcare professional before use
Keep Out Of Reach Of Children
If ingested seek medical help or contact a Poison Control Center immediately
Flammable
Keep away from excessive heat or open flame
Directions:
Adults and Children 12 Years of Age and Older
- Clean and dry the affected area before treatment
- Apply up to 4 times daily
- Wash hands immediately after use
Other Information
- Store in a cool, dry place with lid tightly closed. Keep from freezing.
- If the tamper-evident foil seal is not intact, do not use
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate, Ascorbic
Acid, Amica Montana Flower Extract, Boswellia Serrata Gum Extract, Capric
Triglyceride, Cetyl Alcohol, Cinnamomum Zeylanicum (Cinnamon) Extract,
Curcuma Longa Root Extract, Dimethicone, Dimethyl Sulfoxide, Ethylhexylglycerin,
Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate, lnulin Lauryl Carbamate,
PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Tetrasodium EDTA, Tocopherol,
Triethanolamine, Water.
Questions Or Comments:
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