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| Product NDC Code | 36800-894 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare maximum strength pain relieving analgesic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 866084 | ||||
| Application Number | M017 | ||||
| Labeler Name | Topco Associates LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Menthol 16%
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 generously to affected area ♦ massage into painful area until thoroughly absorbed into skin ♦ repeat if necessary, but not more than 3 to 4 times daily ♦ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask 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., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, 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 minor aches and pains of muscles and joints associated with: ♦ simple backache ♦ arthritis ♦ strains ♦ bruises ♦ sprains
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 Maximum Strength Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) Alcohol Capsaicin Citric Acid Monohydrate Glycerin Isopropyl Myristate Propylene Glycol 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 - 74 mL Bottle Carton NDC 36800-894-01 TopCare health ® COMPARE TO ICY HOT ® ACTIVE INGREDIENT* MAXIMUM STRENGTH Cool n' Heat Roll-On Liquid External Analgesic with Menthol 16% STAIN FREE Powerful, Fast & Effective Pain Relief No-Mess Applicator Keeps Hands Clean OUR PHARMACISTS RECOMMEND 2.5 FL OZ (74 mL) PRINCIPAL DISPLAY PANEL - 74 mL 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
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.Stop 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
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 (1-800222-1222) 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
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 ♦ avoid contact with the eyes and mucous membranes ♦ do not apply to wounds or damaged skin ♦ do not bandage tightly ♦ do not use with heating pads or other heating devices ♦ if redness is present, discontinue use and consult a doctor ♦ if skin irritation occurs, discontinue use ♦ a transient burning sensation may occur upon application but generally disappears in several days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information s tore 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. Test on a small patch of skin before applying generously. When using this product ♦ use only as directed ♦ avoid contact with the eyes and mucous membranes ♦ do not apply to wounds or damaged skin ♦ do not bandage tightly ♦ do not use with heating pads or other heating devices ♦ if redness is present, discontinue use and consult a doctor ♦ if skin irritation occurs, discontinue use ♦ a transient burning sensation may occur upon application but generally disappears in several days Stop 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 Flammable ♦ keep away from fire or flame If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800222-1222) 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