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| Product NDC Code | 72358-101 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pr |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| RxCUI drug identifier | 1293193 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Amphp, 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 0.5%
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.Shake well. 15 minutes to 2 hours before your workout, apply generously to the muscles you use most (30 minutes before water sports). Completely cover each muscle, a palmful per use. Reapply after for added recovery. Wash hands. Adults and children 2 years of age or 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.sodium bicarbonate, water, isopropyl palmitate, lecithin, poloxamer 407, alcohol denat., benzyl alcohol, polygylceryl-4 laurate, hydrated silica, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) seed oil, caprylic/capric triglyceride, sodium hydroxide, fragrance
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.For the temporary relief of pain
Purpose
Information about the drug product’s indications for use.Pain relieving sports lotion
Spl product data elements
Usually a list of ingredients in a drug product.PR Menthol JOJOBA OIL POLYGLYCERYL-3 LAURATE WATER ISOPROPYL PALMITATE COCONUT OIL SODIUM BICARBONATE ALCOHOL BENZYL ALCOHOL HYDRATED SILICA LECITHIN, SOYBEAN POLOXAMER 407 MEDIUM-CHAIN TRIGLYCERIDES SODIUM HYDROXIDE 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.PR Lotion 300 gram tube principal display panel Standard Tube
PR Lotion 20 gram packet principal display panel On-The-Go Packet
PR Lotion 100 gram tube principal display panel Travel Tube
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 use if allergic to any ingredient in this product or sensitive to sodium
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store at 20-25C (68-77F)
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: Symptoms persist for more than 7 days Symptoms 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.Use only as directed. Avoid contact with eyes.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
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