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| Product NDC Code | 36800-470 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare pain relieving analgesic |
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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 | CREAM | ||||
| RxCUI drug identifier | 1010895 | ||||
| Application Number | M017 | ||||
| Labeler Name | Topco Associates 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 HCl 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 of age and older: apply to affected area not more than 3 to 4 times daily ♦ children under 12 years of age: do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol denat., Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearare SE, Phenoxyethanol, Steareth-21, 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 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.TopCare Pain Relieving Analgesic LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) Alcohol ALOE VERA LEAF Aminomethylpropanol Caprylyl Trisiloxane Cetostearyl Alcohol Ceteth-20 Phosphate Dihexadecyl Phosphate Dimethicone EDETATE DISODIUM Ethylhexylglycerin Glyceryl Stearate SE Phenoxyethanol Steareth-21 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 - 77 g Bottle Carton NDC 36800-470-01 TopCare health ® COMPARE TO ASPERCREME ® ODOR FREE WITH 4% LIDOCAINE ACTIVE INGREDIENT* ODOR FREE Pain Relieving Cream with Lidocaine HCl 4% MAXIMUM STRENGTH •Temporary Relief of Pain •Non-Greasy •Fast Acting •With Aloe NET WT 2.7 OZ (77 g) • OUR PHARMACISTS • RECOMMEND PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton
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
DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007
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) immediately.
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? 1-888-423-0139
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.Discontinue use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or 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 ♦ avoid contact with eyes ♦ do not apply to wounds or damaged skin ♦ do not bandage tightly ♦ do not use with heating pads or other heating devices ♦ as with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product ♦ do not use in large quantities, particularly over raw surfaces or blistered areas
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature
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 When using this product ♦ avoid contact with eyes ♦ do not apply to wounds or damaged skin ♦ do not bandage tightly ♦ do not use with heating pads or other heating devices ♦ as with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product ♦ do not use in large quantities, particularly over raw surfaces or blistered areas Discontinue use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
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