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| Product NDC Code | 76162-894 | ||||
|---|---|---|---|---|---|
| Drug Name | Gel cooling pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | part348 | ||||
| Labeler Name | Topco | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reactions Section DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 TOPCO VIJA 0321 QUESTIONS? 1-888-423-0139 [email protected] QUALITY GUARANTEED This products is not manufactured or distributed by Biofreeze Performance Health, distributor of BioFreeze Gel Cold Therapy Pain Relief.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingrident Menthol 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 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5
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 for temporary relief from minor aches and pains of muscles & joints associated with simple backache arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Gel Cooling Pain Relief Menthol MENTHOL MENTHOL ALOE VERA LEAF ARCTIUM LAPPA ROOT ARNICA MONTANA FLOWER FD&C BLUE NO. 1 FRANKINCENSE CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CAMPHOR (NATURAL) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CHAMOMILE GLYCERIN ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE JUNIPER BERRY MELISSA OFFICINALIS WHOLE SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE TROLAMINE water FD&C YELLOW NO. 5
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 TopCare health COMPARE TO BIOFREEZE GEL FAST ACTING MENTHOL PAIN RELIEF Cooling Therapy Pain Relief Pain Relieving Gel with Menthol 4% For Arthritis, Back Pain, Sore Muscles & Joints Disappearing Scent Fast Acting Menthol Pain Relief Paraben-Free 3 FL OZ (89 mL) image description
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 right away.
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.Stop use and ask 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 the eyes do not apply to wounds or damaged skin do not bandage tightly
Storage and handling
Information about safe storage and handling of the drug product.Other information store in a cool dry place with lid closed tightly
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 Flammable, keep away from fire or flame.
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