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Product NDC Code | 83037-015 | ||||
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Drug Name | Dzul arthritis pain relief |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1045482 | ||||
Application Number | M017 | ||||
Labeler Name | Caball Sales, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol 1.5%
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.DIRECTIONS Adults and Children over 12 years Apply a small amount on the affected area. Massage in circular motion, let set for a few seconds. Repeat as necessary, but no more than 3 to 4 times daily. Children under 12 years of age: Do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Eucalyptus Globulus Leaf Oil, Glycereth-26, Polysorbate 60, Methylsulfonylmethane (MSM), Sodium Chondroitin Sulfate, Glucosamine Sulfate, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, Polysorbate 20, Caprylyl Glycol, Sodium Hydroxide, Phenoxyethanol, Hexylene Glycol.
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.USE For the temporary relief of minor aches and pains of muscles and joints associated arthritis
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.DZUL ARTHRITIS PAIN RELIEF Menthol EUCALYPTUS OIL POLYSORBATE 60 DIMETHYL SULFONE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MINERAL OIL GLYCERYL STEARATE SE ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) AMINO ACIDS, WHEAT PANTHENOL ALCOHOL STEARIC ACID CETOSTEARYL ALCOHOL CETYL ALCOHOL DIMETHICONE GLYCERETH-26 SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) GLUCOSAMINE SULFATE CAPRYLYL GLYCOL SODIUM HYDROXIDE SYMPHYTUM OFFICINALE WHOLE HYDROXYPROLINE STEARYL ALCOHOL TRIDECETH-6 HYALURONATE SODIUM SODIUM PYRROLIDONE CARBOXYLATE PHENOXYETHANOL HEXYLENE GLYCOL POLYSORBATE 20 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.DZUL ARTHRITIS PAIN RELIEF CREAM ARTHRITIS
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.If swallowed, get medical help, or contact a Poison Control Center right away.
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.Avoid contact with the eyes or mucous membranes. Do not apply to wounds or damaged skin. Do not apply to the irritated skin or if excessive irritation develops. Do not bandage tightly. Do not use with heating pad or device. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast – feeding Ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Store tightly closed in a dry place at controlled room temperature between 59-86 F (15°-30° C).
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. •Ask a doctor before use if you have redness over affected area.
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