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| Product NDC Code | 72425-201 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relief cream |
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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 | SanaMax Plus 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 Ingredients Menthol 1.25%
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 ■ use only as directed ■ adults and children 12 years of age and older: apply to affected area 3 to 4 times daily ■ children under 12 years of age: ask a doctor before use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Benzyl Alcohol, Cananga Odorata (Ylang Ylang) Flower Oil, Caprylic/Capric Trigl- yceride, Caprylyl Glycol, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Crambe Abyssinica Seed Oil, Cymbopogon Schoenanthus Oil, Ethyl- hexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate, Helichrysum Italicum Flower Oil, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, PEG-40 Hydrogenated Castor Oil, PEG-6, Phenoxyethanol, Pogostemon Cablin (Patchouli) Oil, Polyglyceryl-3 Ricinoleate, Salvia Sclarea (Clary Sage) Oil, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Water/Aqua
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 the 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 Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief Cream MENTHOL MENTHOL MENTHOL BENZYL ALCOHOL CANANGA ODORATA FLOWER MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CETOSTEARYL ALCOHOL CHAMOMILE FLOWER OIL BERGAMOT OIL ORANGE OIL CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL CYMBOPOGON SCHOENANTHUS OIL ETHYLHEXYLGLYCERIN EUCALYPTUS OIL GLYCERIN GLYCERYL MONOSTEARATE HELICHRYSUM ITALICUM FLOWER OIL LAVENDER OIL LECITHIN, SUNFLOWER PEPPERMINT OIL SPEARMINT OIL POLYOXYL 40 HYDROGENATED CASTOR OIL POLYETHYLENE GLYCOL 300 PHENOXYETHANOL POGOSTEMON CABLIN LEAF OIL POLYGLYCERYL-3 RICINOLEATE CLARY SAGE OIL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) WATER
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.Principal Display Package Labeling SanaMax PLUS BALANCED FORMULA SanaMax PLUS PAIN RELIEF CREAM Temporary relief from backache, minor arthritis, muscle and joint pain. Quick Absorbing Paraben Free Non Staining Non-Greasy Non-Burning Fast Relief Relaxing Scent Calming Effect DOCTOR RECOMMENDED WITH 12 ESSENTIAL OILS NET WT 1 OZ (28g) SanaMax PLUS PAIN RELIEF CREAM SanaMax Plus is trusted by medical doctors, pharmacists, physical therapists, chiropractors, massage therapists, podiatrists, and athletic trainers. It applies easily and penetrates quickly for fast temporary relief from sore muscles, backaches, sore joints, and arthritis. SanaMax Plus is a balanced formula that contains 12 essential oils. It is quick absorbing but is not greasy, does not stain, has a relaxing scent, a calming effect, and does not burn. SanaMax Plus is not tested on animals, is made in the USA with USP grade ingredients, is free of parabens, and propylene glycol. Distributed by: Questions or Comments SanaMax Plus LLC sanamaxplus.com McAllen, TX 78501 NDC 72425-201-02 8 60473 00240 2 PE 2020/013 VER 01 BOX TUBE res SanaMax Box 201 SanaMax Tube 201
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have redness over the affected area .
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: ■ on wounds, damaged, broken, or irritated skin ■ with a heating pad ■ on a child under 12 years of age with arthritis-like conditions.
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 to avoid accidental ingestion . If swallowed, get medical help or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information : ■ Store at 68° to 77°F (20° to 25°C)
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 symptoms persist for more than 7 days ■ skin irritation occurs
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 membrane ■ 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.
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