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Product NDC Code | 79804-282 | ||||||
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Drug Name | Pain relief roll on |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 2610122 | ||||||
Application Number | M017 | ||||||
Labeler Name | Eagle Labs Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 6% Camphor 5% Capsaicin 0.025%
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 over 12 years old: Apply to afected area - do not apply more than 4 times daily. Children 12 years or younger: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citrus Fiber, Dimethicone, Isopropyl Alcohol, Jojoba Oil, Phenoxyethanol, Simethicone, Water
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 aches and pains of muscles and joints associated with arthritis, backaches, strains or 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.Pain Relief Roll On Topical Analgesic PHENOXYETHANOL MENTHOL MENTHOL JOJOBA OIL DIMETHICONE ISOPROPYL ALCOHOL WATER CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) CAPSAICIN CAPSAICIN SILICON DIOXIDE CITRUS FRUIT Semi-Translucent
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.Insta Eaze: Roll the Pain Away Insta Eaze Roll the Pain Away
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 ingested get medical help or contact Poison control center immediately: 1-800-222-1222
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 usage immediately and ask a doctor if: Condition worsens or symptoms persist for more than 7 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. Avoid contact with eyes or mucous membranes. Do not apply directly to wounds or damaged skin. Do not use in combination with other ointments, creams, or sprays. Wash hand with cool water after each uyse. Do not use with a heating pad or device.
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.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