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| Product NDC Code | 71304-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Cu pain away pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 416982 | ||||
| Application Number | M017 | ||||
| Labeler Name | Canadian Unique Health Ltd. | ||||
| 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.Active ingredient Menthol 1.25% Purpose Counterirritant
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 (Aloe barbadensis) leaf juice, avocado (Persea gratissima) oil, caprylyl glycol, cetearyl alcohol, coco-caprylate, coconut (Cocos nucifera) oil, cupric oxide, disodium EDTA, isoamyl cocoate, isopropyl palmitate, jojoba (Simmondsia chinensis) seed oil, lavender (Lavandula angustifolia) oil, lemon (Citrus limon) oil, phenoxyethanol, polysorbate 60, silk amino acids, sodium lactate, stearic acid, tea tree (Melaleuca alternifolia) leaf oil, tocopherol
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 Counterirritant
Spl product data elements
Usually a list of ingredients in a drug product.CU Pain Away Pain Relief MENTHOL ALOE AVOCADO OIL CAPRYLYL GLYCOL CETOSTEARYL ALCOHOL COCO-CAPRYLATE COCONUT OIL CUPRIC OXIDE EDETATE DISODIUM ANHYDROUS ISOAMYL COCOATE ISOPROPYL PALMITATE JOJOBA OIL LAVENDER OIL LEMON OIL PHENOXYETHANOL POLYSORBATE 60 AMINO ACIDS, SILK SODIUM LACTATE STEARIC ACID TOCOPHEROL 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.Package Labeling: 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.Drug Facts
Other information Store in a cool dry place Protect from heat and light
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? Call 1-844-893-3085 Monday through Friday, 9-5pm EST or visit www.canadianunique.com
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 irritation of the skin develops If pregnant or breast-feeding, ask a health professional before use.
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 apply to wounds or damaged skin do not bandage 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. Avoid contact with the eyes and mucous membranes. When using this product use only as directed do not apply to wounds or damaged skin do not bandage tightly 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 irritation of the skin develops 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 right away.
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