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| Product NDC Code | 83016-331 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pain relief gel-roll on |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 415974 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | R & Y Group, LLC | ||||||
| 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 4.0% w/w ...... Purpose: Topical 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 ■ Adults and children 12 years of age and older : Rub a thin film over affected areas not more than 4 times daily; massage not necessary ■ Children under 12 years of age : Consult Physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, 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 temporary relief of minor aches and pains of muscles and joints
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 Gel-Roll On Menthol ALCOHOL 95% MENTHOL MENTHOL TROLAMINE WATER SILICON DIOXIDE ILEX PARAGUARIENSIS LEAF ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL, D- ALOE VERA LEAF GLYCERIN FD&C YELLOW NO. 5 FD&C BLUE NO. 1 CAMPHOR (SYNTHETIC) GREEN TEA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE FRANKINCENSE ARNICA MONTANA FLOWER
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.Bottle label: --- Bag (1 bottle) label: --- Bag (3 bottles) label: Bottle label Bag label 21
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.www.theraice.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 reoccur
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 ■ Avoid contact with eyes or mucous membranes ■ Do not apply to wounds or damaged skin ■ Do not use with other ointments, creams, sprays or liniments ■ Do not apply to irritated skin or if excessive irritation develops ■ Do not bandage ■ Wash hands after use with cool water ■ Do not use with heating pad or device ■ Store in a cool dry place
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 Flammable: Keep away from excessive heat or open flame Ask a doctor before use if you have: Sensitive skin
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