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Product NDC Code | 83833-101 | ||||
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Drug Name | Welahead by welmate lidocaine 5% roll-on |
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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 | SOLUTION | ||||
RxCUI drug identifier | 2670601 | ||||
Application Number | M017 | ||||
Labeler Name | OTC PHARM LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocaine HCl 5%
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: apply a thin layer to affeced area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period Children 12 years and younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingrediants purified water, ethyl alcohol, propylene glycol, polysorbate 20, triethanolamine, phenoxyethanol, ethylhexylglycerin, potassium carbomer, aloe vera, glycerin, chonüoitin sulfate, glucosamine sulfate, methylsulfonylmethane
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.Use Temporarily Relieves minor pain
Purpose
Information about the drug product’s indications for use.Purporse Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.WelAhead by Welmate Lidocaine 5% Roll-on Lidocaine 5% CHONDROITIN SULFATE (BOVINE) WATER ALOE VERA LEAF PROPYLENE GLYCOL ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN LIDOCAINE HYDROCHLORIDE ANHYDROUS LIDOCAINE ALCOHOL DIMETHYL SULFONE POLYSORBATE 20 TROLAMINE PHENOXYETHANOL POTASSIUM CARBONATE
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.Label
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.
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 on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than week without consulting a doctor When using this product: use cnly as directed. Read and follow all directions and warnings on this carton do not allow contact with the eyes and mucous membranes do not bandage or apply a local heat (such as heating pads) to the area of use Stop use and aska doctor if condition worsens skin reactions occur, such as rash, itching, redness, irritation, pain, and swelling symptoms persist for more than 7 days or clear up and occur again within a days Flammable keep away from fire or flame If pregnant or breast freding , ask a health professional before use.
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