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| Product NDC Code | 71391-150 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Lidocaine pain relieving |
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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 | TOPICAL | ||||||||
| Dosage Form | PATCH | ||||||||
| RxCUI drug identifier | 1737778 | ||||||||
| Application Number | part348 | ||||||||
| Labeler Name | Unexo Life Sciences Private Limited | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocaine 4.0%
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 over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use Children 12 years of age or younger: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, 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 Temporarily relieves minor pain.
Purpose
Information about the drug product’s indications for use.Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Pain Relieving Lidocaine Lidocaine LIDOCAINE DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS Glycerin Kaolin Methylparaben POLYACRYLIC ACID (250000 MW) Polysorbate 80 Propylene Glycol Propylparaben POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (8000 MW) Tartaric Acid Titanium Dioxide Water
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.PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label NDC: 71391-150-01 LIDOCAINE PAIN RELIEVING PATCH LIDOCAINE 4% / Topical Anesthetic Temporarily relieves pain Stay-Put flexible Patch Easy to apply & remove No-mess, single use application Odor-free Lasts upto 12 hours 1 PATCH 3.93 X 5.5 IN (10cm X 14cm) PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label
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.Drug Facts
Manufactured By: UNEXO LIFE SCIENCES PVT. LTD. B-16. Sector 4, Bawana Industrial Area, Delhi – 110039 (INDIA)
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 More than one patch on your body at a time On cut, irritated or swollen skin On puncture wounds For more than one week without consulting a doctor If you are allergic to any active or inactive ingredients If pouch is damaged or opened.
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 swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments Call 1-888-287-1915
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 a doctor if Condition worsens Redness is present Irritation develops Symptoms persist for more than 7 days or clear up and occur again within a few days You experience signs of skin injury, such as pain, swelling or blistering where the product was applied
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 Use only as directed Read and follow all directions and warnings on this pack Do not allow contact with the eyes Do not use at the same time as other topical analgesics Do not bandage tightly or apply local heat (such as heating pads) to the area of use Do not microwave Dispose of used patch in manner that always keeps product away from children and pets Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
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 Do not use More than one patch on your body at a time On cut, irritated or swollen skin On puncture wounds For more than one week without consulting a doctor If you are allergic to any active or inactive ingredients If pouch is damaged or opened. When using this product Use only as directed Read and follow all directions and warnings on this pack Do not allow contact with the eyes Do not use at the same time as other topical analgesics Do not bandage tightly or apply local heat (such as heating pads) to the area of use Do not microwave Dispose of used patch in manner that always keeps product away from children and pets Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch Stop use and ask a doctor if Condition worsens Redness is present Irritation develops Symptoms persist for more than 7 days or clear up and occur again within a few days You experience signs of skin injury, such as pain, swelling or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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