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| Product NDC Code | 84573-517 | ||||||||||||||||
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| Drug Name | Real time pain relief maxx topical analgesic |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | LOTION | ||||||||||||||||
| RxCUI drug identifier | 1148429 | ||||||||||||||||
| Application Number | M017 | ||||||||||||||||
| Labeler Name | REAL TIME PRODUCTS, INC | ||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 1.5% 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 over 2 years: Apply to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more than 4 times daily. Children 2 years or younger: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Calendula Officinalis Extract, Caprylyl Glycol, Capsaicin, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Chondroitin Sulfate, Coriandrum Sativum (Coriander) Oil, Emu Oil, Glucosamine Sulfate, Glycerin, Hamamelis Virginiana (Witch Hazel) Distillate, Hypericum Perforatum (St.John Wort), Laureth-7, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sorbitol, Tilia Cordata (Linden) Bark Extract.
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: Temporarily relieves minor pain associated with: Arthritis Simple Backache Muscle Strains Sprains Bruises Cramps
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.Real Time Pain Relief Maxx Topical Analgesic MENTHOL ALOE VERA LEAF WATER ARNICA MONTANA FLOWER C13-14 ISOPARAFFIN CALENDULA OFFICINALIS FLOWER CAPRYLYL GLYCOL CAPSAICIN CHAMOMILE CORIANDER EMU OIL GLUCOSAMINE SULFATE GLYCERIN WITCH HAZEL HYPERICUM PERFORATUM WHOLE LAURETH-7 PEPPERMINT OIL DIMETHYL SULFONE PHENOXYETHANOL SALIX ALBA BARK SORBITOL LEVOISOMETHADONE 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: 88ml Label
Package Labeling: 120ml Label2
Package Labeling: 147.8ml Label3
Package Labeling: 210ml Label4
Package Labeling: 354ml Label5
Package Labeling: 473ml Label6
Package Labeling: 1893ml Label010
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
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? 877-787-7180
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: Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days Redness is present Irritation develops
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 membrane 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 When using this product: Use only as directed Avoid contact with eyes or mucous membrane Do not apply to wounds or damaged skin Do not bandage tightly Stop use and ask doctor if: Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days Redness is present Irritation develops 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