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| Product NDC Code | 73240-904 | ||||
|---|---|---|---|---|---|
| Drug Name | Sunmed pain freeze |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | part348 | ||||
| Labeler Name | Sunflora Inc. | ||||
| 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.Menthol ................ 6%
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: Adult 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 physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients /Joo Barbadensis Leaf Extract,Arcium Lappa Roof (Buroock) Extract, Amica Montana Flower Extract, Boswellia Carteni Resin Extract Calendu Officinalis Extract, Camellia Sinensis Leaf Extract,Camphor; CartJomer,FD&C Blue #1,FD&C Yellow #5,Glycenn,llex Paraguanensis (Mate) Leaf Extract oopropyf /Jcoh , oopropyf Myristafe,Melissa Officinalis (LemooBalm)Leaf Extract, Silica,T=heryf Acetate,Tnethanolamine,water,Whole Hemp Extract
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.Temporary relief from minor aches and pains of muscles and joints associated with arthritis,simple backache,strains and sprains.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.SUNMED pain freeze MENTHOL CALENDULA OFFICINALIS WHOLE CAMPHOR (NATURAL) CARBOMER 980 ILEX PARAGUARIENSIS LEAF MELISSA OFFICINALIS LEAF PHENOXYETHANOL ALOE VERA LEAF CANNABIDIOL GLYCERIN ISOPROPYL ALCOHOL CAMELLIA SINENSIS WHOLE FRANKINCENSE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER MENTHOL MENTHOL ARCTIUM LAPPA ROOT ARNICA MONTANA FLOWER SILICON DIOXIDE
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.Sunmed Pain-Freeze Gel with Menthol
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 immediately
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 doctor if condition worsens or symptoms persist for more than 7 days, or clear up and reoccur a gain within 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 contacts with the eyes Of mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin • do not bandage • wash hands after use with cool water • do not use with heating pad or device.
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.For external use only
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