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Product NDC Code | 54633-414 | ||||
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Drug Name | K2 cold therapy |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 259249 | ||||
Application Number | part348 | ||||
Labeler Name | The Podiatree Co | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient: Menthol 10%
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 a thin layer over the affected area not more than 3 to 4 times daily. Children 12 years of age or younger: Consult a doctor. Close cap tightly after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Camphor, Eucalyptus Globulus Leaf Oil, FD&C Blue #1, FD&C Yellow #5, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Oil, SD 40 Alcohol (5%) Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Steareth 2, Steareth 20, Urea, Vitis Vinifera (Grape) Seed Extract, Water (Purified)
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 ASSOCIATED WITH: ARTHRITIS SIMPLE BACKACHE MUSCLE STRAINS 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.K2 Cold Therapy Menthol ALOE VERA LEAF CAMPHOR (NATURAL) EUCALYPTUS GLOBULUS LEAF FD&C BLUE NO. 1 FD&C YELLOW NO. 5 POLYSORBATE 80 ROSMARINUS OFFICINALIS WHOLE ALCOHOL SIMMONDSIA CHINENSIS WHOLE SORBITAN SESQUIOLEATE STEARETH-2 STEARETH-20 UREA VITIS VINIFERA SEED WATER MENTHOL MENTHOL
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.label
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 Suggestions? 1.855.763.8733 or visit us at www.thepodiatreecompany.com . Our commitment to you is 100% satisf ication. If you are not completely satisfied, please contact us for a full refund.
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 Redness is present Irritation develops Symptoms persist for more than 7 days or clear up and reoccur 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 Use only as directed Do not bandage tighlty or use with a heating pad Avoid contact with eyes and mucous membranes Do not apply to wounds or damaged, broken, or irritated skin.
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 Store at controlled room temperature. Do not shake bottle with cap removed.
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.
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