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Product NDC Code | 65121-715 | ||||
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Drug Name | Ecolyptus pain relieving muscle rub |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1488306 | ||||
Application Number | M017 | ||||
Labeler Name | Pure Source, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol 6.0% Purpose External Analgesic
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: For adults and children 2 years and older: Apply to affected area up to 4 times daily. For children under 2 years of age: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aqua [Deionized Water], Caprylic/Capric Triglyceride, Cetearyl Olivate, Citric Acid, Eucalyptus Globulus Oil, Gluconolactone, Glycerin, Potassium Sorbate, SD-Alcohol 38B, Sodium Benzoate, Sorbitan Olivate, Xanthan Gum
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 Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains 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.ecolyptus pain relieving muscle rub MENTHOL WATER MEDIUM-CHAIN TRIGLYCERIDES CETEARYL OLIVATE CITRIC ACID MONOHYDRATE EUCALYPTUS OIL GLUCONOLACTONE GLYCERIN POTASSIUM SORBATE SODIUM BENZOATE SORBITAN OLIVATE XANTHAN GUM 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.ecolyptus pain relieving muscle rub 88.7ml (65121-715-88) EcoLyptus Label
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.ecolyptus pain relieving muscle rub
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: Get into eyes or mucous membranes Apply to wounds or damaged skin Bandage
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. In case of accidental ingestion, seek professional assistance 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 consult a physician if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.
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: Get into eyes or mucous membranes Apply to wounds or damaged skin Bandage Stop use and consult a physician if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center 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