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| Product NDC Code | 51142-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Care science |
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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 | 505G(a)(3) | ||||
| Labeler Name | ASO 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 Adults and children 12 years and over: clean and dry affected area peel film from patch and plastic liner and apply to the skin apply 1 patch at a time to affected area, not more than 3 to 4 times daily wash hands after applying patch remove patch from the skin after at most 8 hours application Children under 12 years of age: do not use, consult a physician before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylic adhesive, polyester fabric
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 pain
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Care Science lidocaine LIDOCAINE LIDOCAINE ETHYLENE-VINYL ACETATE COPOLYMER (15% VINYL ACETATE)
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 CARE SCIENCE 4% LIDOCAINE PAIN RELIEF BLISTER DEFENSE PATCH DESIGNED FOR TOES AND HEELS LASTS UP TO 8 HOURS Maximum OTC Strength For temporary relief of pain associated with pressure and friction Lidocaine in adhesive temporarily numbs pain Flexible Fabric Covers and Protects Skin Durable, Breathable Thin and Flexible Fabric Easily conforms to Skin Product Label
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 large quantities on raw surfaces, blistered areas, wounds or damaged skin if you are allergic to any ingredients of this product
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 put in mouth, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature keep away from excessive heat do not exceed 100 o F (38 o C)
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 skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few 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 do not use other topical products do not allow contact with eyes or mucous membranes apply only to clean, dry, and untreated skin use only as directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health care 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 Do not use large quantities on raw surfaces, blistered areas, wounds or damaged skin if you are allergic to any ingredients of this product When using this product do not use other topical products do not allow contact with eyes or mucous membranes apply only to clean, dry, and untreated skin use only as directed Stop use and ask a doctor if skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding ask a health care professional before use. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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