Otc - Active Ingredient
Menthol 1.5%
Dzul Arthritis Pain Relief Cream
FDA Label NDC 83037-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Caball Sales, Inc. for the product Dzul Arthritis Pain Relief (NDC 83037-015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, use, warnings, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Use
For the temporary relief of minor aches and pains of muscles and joints associated arthritis
Warnings
•For external use only.
•Ask a doctor before use if you have redness over affected area.
Otc - When Using
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast – feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a Poison Control Center right away.
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.
Other Information
Store tightly closed in a dry place at controlled room temperature between 59-86 F (15°-30° C).
Inactive Ingredient
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.
* Please review the disclaimer below.
