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| Product NDC Code | 83295-8000 | ||||
|---|---|---|---|---|---|
| Drug Name | Cinthera |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | CUTANEOUS | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 2559400 | ||||
| Application Number | M017 | ||||
| Labeler Name | Strand Health Group | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Lidocaine 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES For the temporary relief of muscle pain and joint pain associated with: -Backache -Cramps -Soreness -Strains -Discomfort -Neckache
Purpose
Information about the drug product’s indications for use.PURPOSE Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Cinthera Lidocaine CURCUMA LONGA (TURMERIC) ROOT EXTRACT TRIETHANOLAMINE TETRASODIUM EDTA CINNAMON PEG-100 STEARATE WATER AMMONIUM ACRYLOYLDIMETHYLTAURATE TRICAPRIN GLYCERYL STEARATE ASCORBIC ACID INULIN LAURYL CARBAMATE LIDOCAINE LIDOCAINE ARNICA MONTANA FLOWER DIMETHICONE ETHYLHEXYLGLYCERIN EUCALYPTUS GLOBULUS LEAF OIL BOSWELLIA SERRATA GUM EXTRACT CETYL ALCOHOL GLYCERIN ALOE VERA LEAF DIMETHYL SULFOXIDE STEARIC ACID PHENOXYETHANOL TOCOPHEROL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.tube
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.ALLERGY ALERT Local anesthetics may cause methemoglobinemia. If an allergic reaction occurs, stop use and seek medical attention immediately.
FLAMMABLE Keep away from excessive heat or open flame
QUESTIONS OR COMMENTS [email protected]
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN If ingested, seek medical help or contact Poison Control immediately
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT Avoid contact with the eyes, nose, and mouth
Pregnancy or breast feeding
Pregnancy or Breast feedingIF PREGNANT OR BREASTFEEDING Ask a healthcare professional before use
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS: FOR EXTERNAL USE ONLY
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API