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| Product NDC Code | 36800-529 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare pain relief maximum strength |
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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 | LIQUID | ||||
| RxCUI drug identifier | 1987647 | ||||
| Application Number | M017 | ||||
| Labeler Name | TOPCO ASSOCIATES | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine HCI 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 over 12 years : ▪ apply a thin layer to affected 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 ingredients aloe barbadensis leaf juice. Carbomer, disodium EDTA, glycerin, phenyl carbinol, purified water, sodium hydroxide. Questions or comments? 1-866-467-2748 QUALITY GUARANTEED This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.
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.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.TopCare Pain Relief Maximum Strength Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETATE DISODIUM GLYCERIN BENZYL ALCOHOL SODIUM HYDROXIDE 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 NDC# 36800-529-25 +TopCare health ™ COMPARE TO THE ACTIVE INGREDIENT IN ASPERCREME® ODOR FREE WITH 4 % LIDOCAINE* MAXIMUM STRENGTH PAIN RELIEF Roll-On Liquid Lidocaine HCl 4% ODOR FREE • Temporary relief of pain • Helps pain-affected areas • No-touch applicator • Oil-Free • Paraben-Free • Alcohol-Free With Aloe NET WT 2.5 OZ (71 g) CHILD-RESISTANT PACKAGING. CLOSE CAP TIGHTLY AFTER USE. DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 6007 © TOPCO RARA0819 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Aspercreme® Odor Free with 4% Lidocaine. TopCare Health Maximum Strength Pain Relief Roll-On-Liquid
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 ▪ on large areas of the body 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 at 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
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? 1-866-467-2748 QUALITY GUARANTEED This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.
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 ▪ symptoms persist for more than 7 days or clear up and occur again within a few days Flammable ▪ Keep away from fire or flame
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 carton. ▪ do not allow contact with the eyes ▪ do not bandage or apply local heat (such as heating pads) to the area of use
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 Do not use ▪ on large areas of the body or on cut, irritated or swollen skin ▪ on puncture wounds ▪ for more than one week without consulting a doctor When using this product ▪ use only as directed. Read and follow all directions and warnings on this carton. ▪ do not allow contact with the eyes ▪ do not bandage or apply local heat (such as heating pads) to the area of use Stop use and ask a doctor if ▪ condition worsens ▪ symptoms persist for more than 7 days or clear up and occur again within a few days Flammable ▪ Keep away from fire or flame If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away at 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