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| Product NDC Code | 67510-0284 | ||||
|---|---|---|---|---|---|
| Drug Name | Pure-aid |
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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 | 1249758 | ||||
| Application Number | part348 | ||||
| Labeler Name | Kareway Product, Inc. | ||||
| 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% Menthol 1%
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 backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 2 patch for up to 24 hours children 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, 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.Purposes Topical Anesthetic Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Pure-Aid Lidocaine, Menthol DIHYDROXYALUMINUM AMINOACETATE GLYCEROL FORMAL METHYLPARABEN KAOLIN PROPYLPARABEN PROPYLENE GLYCOL TARTARIC ACID TITANIUM DIOXIDE WATER LIDOCAINE LIDOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM POLYACRYLIC ACID (250000 MW) SODIUM POLYACRYLATE (2500000 MW)
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.Package/Label Principal Display Panel Pure-Aid MAXIMUM STRENGTH LIDOCAINE PATCH PLUS MENTHOL Targeted Immediate Pain Relief Desensitizes Aggravated Nerves Dual Action with Lidocaine and Menthol Fast Acting and Long Lasting First Aid for Pain Pain Relieving Ointment on a Breathable Adhesive Pad Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm) each Label pouch
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 1 patch on your body at a time or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor
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 and Pets If swallowed, get medical help or contact a Poison Control Center right away.
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 label. rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not allow contact with the eyes and mucous membranes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics 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.
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