Active Ingredients
Lidocaine 4%
Cinthera Ointment
FDA Label NDC 83295-8000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strand Health Group for the product Cinthera (NDC 83295-8000). 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 active ingredients, purpose, uses, allergy alert, do not use, when using this product, stop use and ask doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anesthetic
Uses
For the temporary relief of muscle pain and joint pain associated with:
-Backache -Cramps -Soreness -Strains -Discomfort -Neckache
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 again within 3 days
If Pregnant Or Breastfeeding
Ask a healthcare professional before use
Keep Out Of Reach Of Children
If ingested, seek medical help or contact Poison Control 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
-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 Barbedensis Leaf Juice, Ammonium Acryloyldimethyltaurate, Ascorbic Acid, Arnica 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, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Steric Acid, Tetrasodium EDTA, Tocopherol, Triethanolamine, Water.
Questions Or Comments
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