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| Product NDC Code | 52000-407 | ||||
|---|---|---|---|---|---|
| Drug Name | Universal pain relief |
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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 | Universal Distribution Center LLC | ||||
| 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 ingredient 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 Adult and Children 12 years of age and over : Clean and dry affected area Remove film from patch and apply to the skin (see illustration) Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Remove patch from the skin after at most 8-hour application Children under 12 years of age : Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, 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 temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Universal PAIN RELIEF Lidocaine LIDOCAINE LIDOCAINE GLYCERIN SODIUM POLYACRYLATE (2500000 MW) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS EDETATE DISODIUM KAOLIN TITANIUM DIOXIDE POLYSORBATE 80 PROPYLENE GLYCOL TARTARIC ACID POLYACRYLIC ACID (250000 MW) POVIDONE K90 METHYLPARABEN PROPYLPARABEN 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.Packaging painreliever01
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.HOT & COLD RELIEF FAST ACTING PAIN RELIEF DESENSITIZE AGGRAVATED NERVES Back Neck Shoulders Knees & Elbows APPLY FOR 8 HOURS CONTAINS FIVE 5.5"X3.94" INDIVIDUALLY PACKED PATCHES HOW TO APPLY 1. Remove patch from outer package 2. Partially peel back protective film 3. Place on affected area 4. Remove remaining film while pressing patch to skin USE COLD For temporary relief of pain associated with: Swelling Sprains & Strains Bumps & Bruises Sports injury Toothache Fever USE HOT For temporary relief of pain associated with: Muscle aches Mild Arthritis Menstrual cramps Joint stiffness Sports injury Mfd and Distributed By: Universal Distribution Center 96 Distribution Boulevard, Edison, NJ 08817 www.universaldc.com Made in P.R.C
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 right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Avoid storing product in direct sunlight Protect product 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 1 patch at a time • On wounds or damaged skin • With a heating pad • If you are allergic to any ingredients of this product When using this product: • Use only as directed • Avoid contact with the eyes, mucous membranes or rashes • Do not bandage tightly Stop use and ask a doctor if: • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering • Conditions worsen • Symptoms persists for more than 7 days • Symptoms clear up and occur again within a few days 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 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